Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
- Conditions
- Primary Peritoneal Cavity CancerFallopian Tube CancerOvarian Cancer
- Registration Number
- NCT00031954
- Lead Sponsor
- AGO Study Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity Based on decision level The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Zentralkrankenhaus
🇩🇪Bremen, Germany
Medizinische Klinik I
🇩🇪Dresden, Germany
Evangelisches Krankenhaus
🇩🇪Dusseldorf, Germany
Staedtisches Krankenhaus FFM-Hoechst
🇩🇪Frankfurt Am Main, Germany
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Frauenklinik der MHH
🇩🇪Hannover, Germany
Christian-Albrechts University of Kiel
🇩🇪Kiel, Germany
Klinik der Otto-v.-Guericke-Universitat
🇩🇪Magdeburg, Germany
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich (Muenchen), Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Klinikum Grosshadern
🇩🇪Munich (Muenchen), Germany
Universitaetsklinikum Charite
🇩🇪Berlin, Germany
Universitaet Ulm
🇩🇪Ulm, Germany
Vincentius Krankenhaus
🇩🇪Karlsruhe, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Universitaetsklinik Goettingen
🇩🇪Gottingen, Germany
Klinik und Poliklinik fuer Kinderheilkunde
🇩🇪Muenster, Germany