Phase 2
N=86
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer
Ovarian Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00489359 ↗Enrolled (actual)
86
Serious AEs
20.9%
Results posted
Jun 2011
Primary outcome: Primary: Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pemetrexed - Phase 1 (Drug); Carboplatin - Phase 1 (Drug); Pemetrexed - Phase 2 (Drug); Carboplatin - Phase 2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2010
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 | — |
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.
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.