Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
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ClinicalTrials.gov Identifier: NCT00489359 |
Recruitment Status :
Completed
First Posted : June 21, 2007
Results First Posted : June 16, 2011
Last Update Posted : June 16, 2011
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Pemetrexed/Carboplatin Phase 1 | Pemetrexed/Carboplatin Phase 2 | Total | |
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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 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 20 participants | 66 participants | 86 participants | |
Female |
20 100.0%
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66 100.0%
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86 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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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. |
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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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00489359 |
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 |