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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.

Outcome Time Frame:

Baseline to measured progressive disease or death up to 82 months

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

6891

NCT ID:

NCT00191646

Start Date:

October 2002

Completion Date:

August 2009

Related Keywords:

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