At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed primary epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage IC, II, III, or IV
- ✓Prior surgery to establish diagnosis with tissue available for histologic evaluation and confirmation of organ of origin
- ✓Enrollment no more than 12 weeks postoperatively
- ✓Willing to receive intravenous (IV) chemotherapy; intraperitoneal therapy not available in this trial
- ✕Epithelial ovarian tumor of low malignant potential (borderline carcinomas)
- ✕Prior radiotherapy to any portion of the abdominal cavity or pelvis
- ✕Prior chemotherapy for any abdominal or pelvic tumor
- ✕Other cancer present within the last 5 years (except non-melanoma skin cancer and specific malignancies) or prior cancer treatment that contraindicates this protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Trial of Induction Chemotherapy With Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Versus Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients With Primary Epithelial Ovarian, Primary Peritoneal Cancer or Fallopian Tube Carcinoma
In Brief
A Phase 3 clinical trial evaluating Gemcitabine, Paclitaxel, and 1 other intervention for Genital Neoplasms, Female and 4 related conditions. Completed, enrolled 919 participants across 55 sites in 2 countries.
Detailed Summary
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.
Study Details
Timeline
Interventions
1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
175 mg/m\^2, IV, Day 1, q 21 days x 6 cycles If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m\^2, IV, 3 hours q 28 days x 12 cycles (1 year) If no complete response, then Gemcitabine arm patients may receive 175 mg/m\^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity
Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles