Conditions

Ovarian Cancer Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
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.
First treatment to toxicity (up to 18 months)
Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)
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
baseline to measured progressive disease (PD) (up to 18 months)

Secondary Outcomes (12)

Phase 1 - Number of Dose-Limiting Toxicities (DLTs)
baseline through end of Phase 1 (up to 18 months)
Phase 1 - Number of Participants With Adverse Events (Toxicity)
baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Dose of Pemetrexed for Phase 2
baseline measured to progressive disease (up to 18 months)
Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2
baseline measured to progressive disease (up to 18 months)
Phase 1 - Number of Participants With Tumor Response
baseline measured to progressive disease (up to 18 months)
+7 more secondary outcomes

Study Arms (2)

Pemetrexed/Carboplatin Phase 1

EXPERIMENTAL

Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin 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.

Drug: Pemetrexed - Phase 1Drug: Carboplatin - Phase 1

Pemetrexed/Carboplatin Phase 2

EXPERIMENTAL

Pemetrexed was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin 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.

Drug: Pemetrexed - Phase 2Drug: Carboplatin - Phase 2

Interventions

Pemetrexed - Phase 1DRUG

500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)

Also known as: LY231514, Alimta

Pemetrexed/Carboplatin Phase 1

Carboplatin - Phase 1DRUG

area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)

Pemetrexed/Carboplatin Phase 1

Pemetrexed - Phase 2DRUG

Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles

Also known as: LY231514, Alimta

Pemetrexed/Carboplatin Phase 2

Carboplatin - Phase 2DRUG

Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles

Pemetrexed/Carboplatin Phase 2

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology
Patients must have recurrent ovarian cancer which is sensitive to platinum therapy
Prior radiation therapy is allowed
Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.

You may not qualify if:

More than 2 lines of therapy for ovarian or primary peritoneal cancer.
Pregnant or breast feeding.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Contact the study team to confirm eligibility.