An Ovarian, Primary Peritoneal or Fallopian Tube Cancer Study for Patients That Have Not Received Prior Chemotherapy
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| ClinicalTrials.gov Identifier: NCT00191646 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : September 9, 2010
Last Update Posted : March 4, 2011
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms | Drug: Gemcitabine Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 919 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | October 2002 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | August 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gemcitabine/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
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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 Other Names:
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 |
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Active Comparator: Paclitaxel/Carboplatin
Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
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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 |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: 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 :
- Proportion of Participants With Response (Response Rate) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191646
Locations
Show 55 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191646 |
| Other Study ID Numbers: |
6891 B9E-US-S302 ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | September 9, 2010 |
| Last Update Posted: | March 4, 2011 |
| Last Verified: | February 2011 |
Additional relevant MeSH terms:
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Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Genital Neoplasms, Female Pelvic Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Gemcitabine Paclitaxel Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |