An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
- Conditions
- Genital Neoplasms, FemaleFallopian Tube NeoplasmsOvarian NeoplasmsPelvic NeoplasmsPeritoneal Neoplasms
- Interventions
- Registration Number
- NCT00191646
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 919
- Patients with a histologic diagnosis of primary peritoneal carcinoma, epithelial ovarian carcinoma or fallopian tube carcinoma Stage IC, II, III or IV.
- All patients must have had surgery for fallopian, ovarian or peritoneal carcinoma to establish the diagnosis and have tissue available for histologic evaluation and confirmation of organ of origin.
- Patients must be enrolled no more than twelve weeks postoperatively.
- Patients must be willing to receive their chemotherapy drugs intravenously, as intraperitoneal therapy is not part of this trial.
Key
- Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (Borderline carcinomas) are not eligible.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded
- With the exception of non-melanoma skin cancer and other specific malignancies patients who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gemcitabine/Carboplatin Carboplatin Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles Gemcitabine/Carboplatin Gemcitabine Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles Paclitaxel/Carboplatin Paclitaxel Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles Paclitaxel/Carboplatin Carboplatin Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Baseline to measured progressive disease or death up to 82 months 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.
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Response (Response Rate) Baseline to measured progressive disease up to 82 months Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions \[TL\]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).
Time to Treatment Failure Baseline to stopping treatment up to 82 months Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have 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.
Overall Survival Baseline to death from any cause up to 82 months Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. 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.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇵🇷San Juan, Puerto Rico