Trials / Completed
CompletedNCT00102414
Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Ovarian Cancer
A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 356 (planned)
- Sponsor
- AGO Study Group · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to compare the time to progressive disease in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Patients will have advanced epithelial ovarian cancer and have failed first-line platinum-containing therapy 6 months after treatment discontinuation.
Detailed description
Carboplatin is commonly used for the treatment of ovarian cancer in first- and second-line therapy. The efficacy of gemcitabine in ovarian carcinoma was researched in various Phase 2 studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine |
Timeline
- Start date
- 1999-09-01
- Completion
- 2004-11-01
- First posted
- 2005-01-31
- Last updated
- 2006-11-14
Source: ClinicalTrials.gov record NCT00102414. Inclusion in this directory is not an endorsement.