Phase 2
Completed N=50
Gemcitabine in Ovarian Cancer
Source: ClinicalTrials.gov NCT00191334 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Best Overall Tumor Response — 6; 25; 10; 5 participants
Summary
The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Tumor Response |
6; 25; 10; 5; 4 | — |
| SECONDARY Duration of Response |
37.0 | — |
| SECONDARY Time to Progressive Disease |
45.1 | — |
| SECONDARY Time to Treatment Failure |
38.4 | — |
| SECONDARY Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade |
34; 6; 2; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- ECOG = 0-2
- Operated patients
- disease stage III-IV
Exclusion Criteria
- No prior chemotherapy or radiation therapy
Data sourced from ClinicalTrials.gov (NCT00191334). 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.