Trials / Completed
CompletedNCT00031954
Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- AGO Study Group · Academic / Other
- Sex
- Female
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.
Detailed description
OBJECTIVES: * Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma. * Determine the response rate of patients treated with this regimen. * Determine the time to progression and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | |
| DRUG | gemcitabine hydrochloride | |
| DRUG | paclitaxel |
Timeline
- Start date
- 2001-08-01
- Primary completion
- 2004-04-01
- First posted
- 2003-07-01
- Last updated
- 2015-12-23
Locations
18 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00031954. Inclusion in this directory is not an endorsement.