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Trial record 22 of 533 for:    "Primary Peritoneal Carcinoma"

Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00489359
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : June 16, 2011
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Primary Peritoneal Cancer
Interventions Drug: Pemetrexed - Phase 1
Drug: Carboplatin - Phase 1
Drug: Pemetrexed - Phase 2
Drug: Carboplatin - Phase 2
Enrollment 86
Recruitment Details  
Pre-assignment Details Phase 1 and Phase 2 were conducted in different participants (i.e., Phase 1 participants did not also participate in Phase 2).
Arm/Group Title Pemetrexed/Carboplatin Phase 1 Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Period Title: Overall Study
Started 20 66
Completed 13 [1] 37 [1]
Not Completed 7 29
Reason Not Completed
Death             0             2
Progressive Disease             5             6
Lost to Follow-up             1             0
Withdrawal by Subject             1             5
Adverse Event             0             16
[1]
Received at least 6 cycles of therapy. Not completed implies participant received <6 cycles.
Arm/Group Title Pemetrexed/Carboplatin Phase 1 Pemetrexed/Carboplatin Phase 2 Total
Hide Arm/Group Description Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Total of all reporting groups
Overall Number of Baseline Participants 20 66 86
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 66 participants 86 participants
56.99  (11.06) 57.71  (10.44) 57.54  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
Female
20
 100.0%
66
 100.0%
86
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
Caucasian 20 59 79
Hispanic 0 7 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
Canada 0 7 7
Argentina 0 14 14
Poland 0 5 5
Germany 20 31 51
Sweden 0 9 9
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
ECOG Status 0 3 46 49
ECOG Status 1 17 20 37
[1]
Measure Description:

The Eastern Cooperative Oncology Group (ECOG) score is an overall assessment of the functional/physical performance of the patient. Scores are:

0=Fully active, able to carry on all pre-disease performance without restriction. 1=Restricted in strenuous activity but ambulatory and able to carry out work of a sedentary nature. 2=Ambulatory and capable of self care but unable to carry out any work activities: up and about more than 50% of time. 3=Capable of only limited self care, confined to bed or chair more than 50% of waking hours. 4=Completely disabled, cannot carry on any self care.

Tumor Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
Ovarian Cancer 15 61 76
Peritoneal Cancer 5 5 10
Platinum-free interval   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 66 participants 86 participants
<6 months 0 3 3
6-12 months 6 23 29
>12 months 14 40 54
[1]
Measure Description: The time elapsed since completing platinum-based therapy.
1.Primary Outcome
Title Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
Hide Description MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.
Time Frame First treatment to toxicity (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
MTD was not determined in this study, so zero participants were analyzed.
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)
Hide Description

Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.

Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100

Time Frame baseline to measured progressive disease (PD) (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.8
(21.3 to 46.0)
3.Secondary Outcome
Title Phase 1 - Number of Dose-Limiting Toxicities (DLTs)
Hide Description

The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).

Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).

Treatment delay more than 1 week due to toxicity.

Time Frame baseline through end of Phase 1 (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: DLT events
Number of DLT Events 1
DLT Event: Grade 4 Neutropenia 1
4.Secondary Outcome
Title Phase 1 - Number of Participants With Adverse Events (Toxicity)
Hide Description A listing of adverse events is located in the Reported Adverse Event module.
Time Frame baseline measured to progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Events 2
Other Adverse Events 19
5.Secondary Outcome
Title Phase 1 - Recommended Dose of Pemetrexed for Phase 2
Hide Description MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.
Time Frame baseline measured to progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: mg/m^2 (milligrams per square meter)
500
6.Secondary Outcome
Title Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2
Hide Description MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).
Time Frame baseline measured to progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: mg/mL*min
6
7.Secondary Outcome
Title Phase 1 - Number of Participants With Tumor Response
Hide Description Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame baseline measured to progressive disease (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 1
Hide Arm/Group Description:

Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Complete Response (CR) 12
Partial Response (PR) 4
Stable Disease (SD) 1
Progressive Disease (PD) 2
8.Secondary Outcome
Title Phase 2 - Time to Response (TTR)
Hide Description Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame First treatment to response (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.4 to 2.8)
9.Secondary Outcome
Title Phase 2 - Duration of Response (DOR)
Hide Description Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.
Time Frame time of response to progressive disease (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: Months
9.1
(6.9 to 10.2)
10.Secondary Outcome
Title Phase 2 - Time to Disease Progression
Hide Description Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.
Time Frame baseline to measured progressive disease (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined using RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
9.5
(8.3 to 11.3)
11.Secondary Outcome
Title Phase 2 - Time to Treatment Failure
Hide Description Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.
Time Frame First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
7.1
(4.6 to 8.5)
12.Secondary Outcome
Title Phase 2 - Overall Survival
Hide Description Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.
Time Frame baseline to date of death from any cause (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Qualified (PQ) population. This analysis was not done due to the high number of censored patients.
Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Phase 2 - Number of Participants With Adverse Events (Toxicity)
Hide Description A listing of adverse events is located in the Reported Adverse Event module.
Time Frame baseline through end of Phase 2 (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).
Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 15
Other Adverse Events 63
14.Secondary Outcome
Title Phase 2 - Progression-Free Survival
Hide Description Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.
Time Frame baseline to measured progressive disease (up to 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description

Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:

Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST.

Arm/Group Title Pemetrexed/Carboplatin Phase 2
Hide Arm/Group Description:
Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Months
9.4
(8.3 to 11.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are reported regardless of potential relatedness to study drug or Grade (severity).
 
Arm/Group Title Pemetrexed 500 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 6 (Phase 1) Pemetrexed 700 + Carboplatin AUC 6 (Phase 1) Pemetrexed 800 + Carboplatin AUC 6 (Phase 1) Pemetrexed 900 + Carboplatin AUC 6 (Phase 1) Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)
Hide Arm/Group Description Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.

Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.

All-Cause Mortality
Pemetrexed 500 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 6 (Phase 1) Pemetrexed 700 + Carboplatin AUC 6 (Phase 1) Pemetrexed 800 + Carboplatin AUC 6 (Phase 1) Pemetrexed 900 + Carboplatin AUC 6 (Phase 1) Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed 500 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 6 (Phase 1) Pemetrexed 700 + Carboplatin AUC 6 (Phase 1) Pemetrexed 800 + Carboplatin AUC 6 (Phase 1) Pemetrexed 900 + Carboplatin AUC 6 (Phase 1) Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      1/3 (33.33%)      1/3 (33.33%)      15/66 (22.73%)    
Blood and lymphatic system disorders               
Anaemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 3/66 (4.55%)  5
Pancytopenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Thrombocytopenia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Cardiac disorders               
Tachycardia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Gastrointestinal disorders               
Abdominal pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Ascites  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Constipation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/66 (0.00%)  0
Gastrointestinal haemorrhage  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Ileus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Nausea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Subileus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Umbilical hernia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
General disorders               
Multi-organ failure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Immune system disorders               
Drug hypersensitivity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/66 (4.55%)  3
Infections and infestations               
Bronchopulmonary aspergillosis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Herpes zoster  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Sepsis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Urinary tract infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Zygomycosis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Renal and urinary disorders               
Renal failure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Renal failure acute  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Respiratory, thoracic and mediastinal disorders               
Dyspnoea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Pleural effusion  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Pulmonary oedema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed 500 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 5 (Phase 1) Pemetrexed 600 + Carboplatin AUC 6 (Phase 1) Pemetrexed 700 + Carboplatin AUC 6 (Phase 1) Pemetrexed 800 + Carboplatin AUC 6 (Phase 1) Pemetrexed 900 + Carboplatin AUC 6 (Phase 1) Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      2/3 (66.67%)      63/66 (95.45%)    
Blood and lymphatic system disorders               
Anaemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 19/66 (28.79%)  32
Leukopenia  1  0/4 (0.00%)  0 2/3 (66.67%)  2 2/4 (50.00%)  2 1/3 (33.33%)  2 2/3 (66.67%)  4 0/3 (0.00%)  0 20/66 (30.30%)  65
Neutropenia  1  0/4 (0.00%)  0 2/3 (66.67%)  4 3/4 (75.00%)  3 1/3 (33.33%)  5 2/3 (66.67%)  3 0/3 (0.00%)  0 32/66 (48.48%)  109
Thrombocytopenia  1  2/4 (50.00%)  3 1/3 (33.33%)  1 3/4 (75.00%)  5 3/3 (100.00%)  3 2/3 (66.67%)  2 0/3 (0.00%)  0 14/66 (21.21%)  41
Ear and labyrinth disorders               
Tinnitus  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Vertigo  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Eye disorders               
Conjunctivitis  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Eye pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Keratoconjunctivitis sicca  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Lacrimation increased  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 10/66 (15.15%)  19
Visual acuity reduced  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  2 0/66 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  2/4 (50.00%)  2 2/3 (66.67%)  7 1/4 (25.00%)  1 1/3 (33.33%)  1 2/3 (66.67%)  3 0/3 (0.00%)  0 9/66 (13.64%)  11
Abdominal pain upper  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  4
Cheilitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Constipation  1  4/4 (100.00%)  24 2/3 (66.67%)  12 2/4 (50.00%)  3 3/3 (100.00%)  9 1/3 (33.33%)  1 2/3 (66.67%)  4 21/66 (31.82%)  39
Diarrhoea  1  0/4 (0.00%)  0 1/3 (33.33%)  2 1/4 (25.00%)  1 1/3 (33.33%)  2 2/3 (66.67%)  5 0/3 (0.00%)  0 10/66 (15.15%)  16
Dry mouth  1  2/4 (50.00%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  3
Dyspepsia  1  2/4 (50.00%)  4 0/3 (0.00%)  0 1/4 (25.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/66 (7.58%)  6
Flatulence  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Gingivitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Nausea  1  4/4 (100.00%)  15 2/3 (66.67%)  10 3/4 (75.00%)  9 3/3 (100.00%)  12 3/3 (100.00%)  12 2/3 (66.67%)  5 42/66 (63.64%)  108
Salivary hypersecretion  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Stomatitis  1  3/4 (75.00%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  5 1/3 (33.33%)  1 10/66 (15.15%)  13
Tongue discolouration  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Vomiting  1  2/4 (50.00%)  2 2/3 (66.67%)  5 4/4 (100.00%)  8 3/3 (100.00%)  13 3/3 (100.00%)  8 1/3 (33.33%)  1 27/66 (40.91%)  45
General disorders               
Chills  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  2
Face oedema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Fatigue  1  3/4 (75.00%)  15 2/3 (66.67%)  2 4/4 (100.00%)  7 2/3 (66.67%)  3 3/3 (100.00%)  5 1/3 (33.33%)  2 33/66 (50.00%)  57
Mucosal inflammation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 10/66 (15.15%)  18
Oedema peripheral  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 5/66 (7.58%)  8
Pain  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Pyrexia  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  5
Immune system disorders               
Drug hypersensitivity  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 17/66 (25.76%)  41
Hypersensitivity  1  1/4 (25.00%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/66 (1.52%)  2
Infections and infestations               
Cystitis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  4
Influenza  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Nasopharyngitis  1  2/4 (50.00%)  2 2/3 (66.67%)  2 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 7/66 (10.61%)  7
Investigations               
Alanine aminotransferase increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 8/66 (12.12%)  11
Aspartate aminotransferase increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 6/66 (9.09%)  10
Blood glucose increased  1  0/4 (0.00%)  0 1/3 (33.33%)  3 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Haemoglobin  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Haemoglobin decreased  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 18/66 (27.27%)  27
Neutrophil count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 10/66 (15.15%)  44
Platelet count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 16/66 (24.24%)  40
White blood cell count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  15
Metabolism and nutrition disorders               
Anorexia  1  0/4 (0.00%)  0 1/3 (33.33%)  2 2/4 (50.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 5/66 (7.58%)  8
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  4 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Back pain  1  3/4 (75.00%)  3 0/3 (0.00%)  0 2/4 (50.00%)  3 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/66 (3.03%)  2
Bone pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Joint swelling  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/66 (0.00%)  0
Musculoskeletal pain  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Myalgia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Pain in extremity  1  0/4 (0.00%)  0 2/3 (66.67%)  3 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Nervous system disorders               
Ageusia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/66 (0.00%)  0
Dizziness  1  0/4 (0.00%)  0 2/3 (66.67%)  2 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 6/66 (9.09%)  6
Headache  1  2/4 (50.00%)  4 3/3 (100.00%)  6 3/4 (75.00%)  6 1/3 (33.33%)  1 1/3 (33.33%)  1 2/3 (66.67%)  2 5/66 (7.58%)  10
Neuropathy peripheral  1  1/4 (25.00%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Paraesthesia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 2/3 (66.67%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Peripheral sensory neuropathy  1  0/4 (0.00%)  0 2/3 (66.67%)  2 1/4 (25.00%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 6/66 (9.09%)  7
Polyneuropathy  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Psychiatric disorders               
Insomnia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  4
Sleep disorder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Renal and urinary disorders               
Polyuria  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough  1  1/4 (25.00%)  3 1/3 (33.33%)  1 1/4 (25.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/66 (4.55%)  3
Dry throat  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/66 (0.00%)  0
Dysphonia  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Dyspnoea  1  1/4 (25.00%)  2 2/3 (66.67%)  2 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 4/66 (6.06%)  6
Epistaxis  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Nasal mucosal disorder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/66 (0.00%)  0
Oropharyngeal pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  2
Rhinitis allergic  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 0/3 (0.00%)  0 0/66 (0.00%)  0
Skin and subcutaneous tissue disorders               
Alopecia  1  2/4 (50.00%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 2/3 (66.67%)  2 0/3 (0.00%)  0 18/66 (27.27%)  19
Dry skin  1  0/4 (0.00%)  0 2/3 (66.67%)  2 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 4/66 (6.06%)  4
Eczema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Erythema  1  0/4 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Hyperhidrosis  1  1/4 (25.00%)  3 1/3 (33.33%)  3 2/4 (50.00%)  6 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Leukoplakia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Night sweats  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Pruritus  1  1/4 (25.00%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 6/66 (9.09%)  10
Rash  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 10/66 (15.15%)  13
Scar pain  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Skin hyperpigmentation  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/66 (1.52%)  1
Swelling face  1  0/4 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/66 (0.00%)  0
Vascular disorders               
Flushing  1  1/4 (25.00%)  1 2/3 (66.67%)  5 3/4 (75.00%)  3 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  3 6/66 (9.09%)  12
Hot flush  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 2/66 (3.03%)  2
Lymphoedema  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/66 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications:
Bookman MA. 2006. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. J Clin Oncol 24 (suppl 18S). Abstract 5002.
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00489359     History of Changes
Other Study ID Numbers: 9516
H3E-MC-JMHH ( Other Identifier: Eli Lilly and Company )
First Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: February 17, 2011
Results First Posted: June 16, 2011
Last Update Posted: June 16, 2011