Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00102375
- Lead Sponsor
- AGO Study Group
- Brief Summary
The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.
- Detailed Description
Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.
Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 900
-
Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
-
International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
-
No prior chemo- or radiotherapy
-
Adequate hematologic, renal and hepatic function:
- ANC ≥ 1.5 x 10^9/L,
- Platelet counts ≥ 100 x 10^9/L,
- Total bilirubin ≤ 1.5 x upper normal limit,
- Alkaline Phosphatase ≤ 3 x upper normal limit,
- Serum creatinine ≤ 1.25 upper normal limit,
- Estimated GFR ≥ 60 ml/min
-
Performance status 0-2 (ECOG)
-
Life expectancy must be greater than 12 weeks
- Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
- Prior treatment with chemo- or radiotherapy
- Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
- History of congestive heart failure
- Symptomatic brain metastasis
- Complete bowel obstruction
- Dementia
- Active infection or other serious underlying medical condition
- Pre-existing motor or sensory neurologic pathology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Survival
- Secondary Outcome Measures
Name Time Method Progression-free survival Response rate Response duration Toxicities Quality of Life
Trial Locations
- Locations (15)
University Clinic Carl Gustav Carus, Gynecological hospital
🇩🇪Dresden, Germany
Gynecologic Hospital of the Medical Facilities RWTH
🇩🇪Aachen, Germany
University Gynecologic Hospital Grosshadern
🇩🇪Muenchen, Germany
Clinic for Gynecology
🇩🇪Muenster, Germany
University Gynecological Hospital
🇩🇪Ulm, Germany
Clinic for Gynecology and Gyn. Oncology, Humboldt University
🇩🇪Berlin, Germany
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
🇩🇪Kiel, Germany
St. Vincentius Gynecologic Hospital
🇩🇪Karlsruhe, Germany
Gynecologic Hospital
🇩🇪Duesseldorf, Germany
University Gynecologic Hospital "rechts der Isar"
🇩🇪Muenchen, Germany
Gynecological Clinic of the Medical University
🇩🇪Hannover, Germany
University Gynecologic Hospital
🇩🇪Tuebingen, Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
🇩🇪Greifswald, Germany
Clinic for Gnyecology and gyn. Oncology HSK
🇩🇪Wiesbaden, Germany
Otto-von-Guericke University, University Gynecological Hospital
🇩🇪Magdeburg, Germany