NCT00191646

An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 919 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.

Conditions

• Genital Neoplasms, Female
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Pelvic Neoplasms
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	Gemcitabine	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
DRUG	Paclitaxel	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
DRUG	Carboplatin	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

Timeline

• Start date: 2002-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2005-09-19
• Last updated: 2011-03-04
• Results posted: 2010-09-09

Locations

55 sites across 2 countries: United States, Puerto Rico