Status:
COMPLETED
Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer
Lead Sponsor:
AGO Study Group
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 c...
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00102375
Start Date
December 1 1999
End Date
October 1 2004
Last Update
August 4 2006
Active Locations (18)
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1
Gynecologic Hospital of the Medical Facilities RWTH
Aachen, Germany, 52074
2
Clinic for Gynecology and Gyn. Oncology, Humboldt University
Berlin, Germany, 10117
3
University Clinic Carl Gustav Carus, Gynecological hospital
Dresden, Germany, 01307
4
Gynecologic Hospital
Düsseldorf, Germany, 40217