Phase 2
N=50
Gemcitabine in Ovarian Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00191334 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Mar 2009
Primary outcome: Primary: Best Overall Tumor Response — 6; 25; 10; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- gemcitabine (Drug); cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2007
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 | — |
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
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.