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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Phase 1 and Phase 2 were conducted in different participants (i.e., Phase 1 participants did not also participate in Phase 2).

Reporting Groups

	Description
Pemetrexed/Carboplatin Phase 1	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/Carboplatin Phase 2	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.

Participant Flow:   Overall Study

	Pemetrexed/Carboplatin Phase 1	Pemetrexed/Carboplatin Phase 2
STARTED	20	66
COMPLETED	13 [1]	37 [1]
NOT COMPLETED	7	29
Death	0	2
Progressive Disease	5	6
Lost to Follow-up	1	0
Withdrawal by Subject	1	5
Adverse Event	0	16

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Pemetrexed/Carboplatin Phase 1	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/Carboplatin Phase 2	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	Total of all reporting groups

Baseline Measures

	Pemetrexed/Carboplatin Phase 1	Pemetrexed/Carboplatin Phase 2	Total
Overall Participants Analyzed  [Units: Participants]	20	66	86
Age  [Units: Years] Mean (Standard Deviation)	56.99  (11.06)	57.71  (10.44)	57.54  (10.52)
Gender  [Units: Participants]
Female	20	66	86
Male	0	0	0
Race/Ethnicity, Customized  [Units: Participants]
Caucasian	20	59	79
Hispanic	0	7	7
Region of Enrollment  [Units: Participants]
Canada	0	7	7
Argentina	0	14	14
Poland	0	5	5
Germany	20	31	51
Sweden	0	9	9
Performance Status [1]  [Units: Participants]
ECOG Status 0	3	46	49
ECOG Status 1	17	20	37
[1] 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  [Units: Participants]
Ovarian Cancer	15	61	76
Peritoneal Cancer	5	5	10
Platinum-free interval [1]  [Units: Participants]
<6 months	0	3	3
6-12 months	6	23	29
>12 months	14	40	54
[1] The time elapsed since completing platinum-based therapy.

1.  Primary:

Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin   [ Time Frame: First treatment to toxicity (up to 18 months) ]

2.  Primary:

Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)   [ Time Frame: baseline to measured progressive disease (PD) (up to 18 months) ]

3.  Secondary:

Phase 1 - Number of Dose-Limiting Toxicities (DLTs)   [ Time Frame: baseline through end of Phase 1 (up to 18 months) ]

4.  Secondary:

Phase 1 - Number of Participants With Adverse Events (Toxicity)   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]

5.  Secondary:

Phase 1 - Recommended Dose of Pemetrexed for Phase 2   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]

6.  Secondary:

Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]

7.  Secondary:

Phase 1 - Number of Participants With Tumor Response   [ Time Frame: baseline measured to progressive disease (up to 18 months) ]

8.  Secondary:

Phase 2 - Time to Response (TTR)   [ Time Frame: First treatment to response (up to 31 months) ]

9.  Secondary:

Phase 2 - Duration of Response (DOR)   [ Time Frame: time of response to progressive disease (up to 31 months) ]

10.  Secondary:

Phase 2 - Time to Disease Progression   [ Time Frame: baseline to measured progressive disease (up to 31 months) ]

11.  Secondary:

Phase 2 - Time to Treatment Failure   [ Time Frame: First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months) ]

12.  Secondary:

Phase 2 - Overall Survival   [ Time Frame: baseline to date of death from any cause (up to 31 months) ]

13.  Secondary:

Phase 2 - Number of Participants With Adverse Events (Toxicity)   [ Time Frame: baseline through end of Phase 2 (up to 31 months) ]

14.  Secondary:

Phase 2 - Progression-Free Survival   [ Time Frame: baseline to measured progressive disease (up to 31 months) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.