Phase 2
Completed N=86
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
Ovarian Cancer · Primary Peritoneal Cancer
Source: ClinicalTrials.gov NCT00489359 ↗
Enrolled (actual)
86
Serious AEs
20.9%
Results posted
Jun 2011
Primary outcomePrimary: Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
Summary
The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin |
— | — |
| PRIMARY Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate) |
32.8 | — |
| SECONDARY Phase 1 - Number of Dose-Limiting Toxicities (DLTs) |
1; 1 | — |
| SECONDARY Phase 1 - Number of Participants With Adverse Events (Toxicity) |
2; 19 | — |
| SECONDARY Phase 1 - Recommended Dose of Pemetrexed for Phase 2 |
500 | — |
| SECONDARY Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2 |
6 | — |
| SECONDARY Phase 1 - Number of Participants With Tumor Response |
12; 4; 1; 2 | — |
| SECONDARY Phase 2 - Time to Response (TTR) |
1.8 | — |
| SECONDARY Phase 2 - Duration of Response (DOR) |
9.1 | — |
| SECONDARY Phase 2 - Time to Disease Progression |
9.5 | — |
| SECONDARY Phase 2 - Time to Treatment Failure |
7.1 | — |
| SECONDARY Phase 2 - Overall Survival |
— | — |
| SECONDARY Phase 2 - Number of Participants With Adverse Events (Toxicity) |
15; 63 | — |
| SECONDARY Phase 2 - Progression-Free Survival |
9.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00489359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.