Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Treatments: Carboplatin; Paclitaxel; Topotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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