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

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 Overview

• Status: Completed
• Conditions: Genital Neoplasms, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Pelvic Neoplasms
• Intervention / Treatment: Drug: Gemcitabine; Drug: Carboplatin; Drug: Paclitaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 919
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 009362712
    • 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.
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
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  • Arkansas
    • Little Rock, Arkansas, United States, 72205
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  • California
    • Los Gatos, California, United States, 95032
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    • Modesto, California, United States, 95350
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    • San Diego, California, United States, 92121
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  • Colorado
    • Englewood, Colorado, United States, 80113
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  • Delaware
    • Newark, Delaware, United States, 19713
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  • Florida
    • Fort Myers, Florida, United States, 33901
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    • South Miami, Florida, United States, 33143
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    • Sunrise, Florida, United States, 33323
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  • Georgia
    • Atlanta, Georgia, United States, 30342
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    • Savannah, Georgia, United States, 31404
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  • Illinois
    • Palatine, Illinois, United States, 60067
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  • Indiana
    • Indianapolis, Indiana, United States, 46260
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    • South Bend, Indiana, United States, 46617
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  • Louisiana
    • Metairie, Louisiana, United States, 70006
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    • New Orleans, Louisiana, United States, 70121
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  • Maine
    • Scarborough, Maine, United States, 04074
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  • Michigan
    • Detroit, Michigan, United States, 48201
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    • Grand Rapids, Michigan, United States, 49546
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  • Minnesota
    • Duluth, Minnesota, United States, 55805
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    • Minneapolis, Minnesota, United States, 55455
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    • Rochester, Minnesota, United States, 55905
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  • Missouri
    • Kansas City, Missouri, United States, 64111
      • 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.
    • St Louis, Missouri, United States, 63141
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  • Montana
    • Billings, Montana, United States, 59107
      • 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.
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • 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.
    • Reno, Nevada, United States, 89502
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  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • 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.
  • New York
    • Rochester, New York, United States, 14620
      • 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.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • 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.
    • Charlotte, North Carolina, United States, 28204
      • 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.
    • Durham, North Carolina, United States, 27710
      • 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.
    • Greenville, North Carolina, United States, 27858
      • 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.
  • Ohio
    • Columbus, Ohio, United States, 43222
      • 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.
    • Dayton, Ohio, United States, 45429
      • 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.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • 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.
  • Pennsylvania
    • Dunmore, Pennsylvania, United States, 18512
      • 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.
    • Johnstown, Pennsylvania, United States, 15905
      • 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.
    • Pittsburgh, Pennsylvania, United States, 15224
      • 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.
    • Sayre, Pennsylvania, United States, 18840
      • 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.
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • 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.
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • 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.
    • Columbia, South Carolina, United States, 29210
      • 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.
    • Greenville, South Carolina, United States, 29601
      • 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.
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • 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.
    • Knoxville, Tennessee, United States, 37920
      • 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.
    • Memphis, Tennessee, United States, 38120
      • 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.
  • Texas
    • Austin, Texas, United States, 78735
      • 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.
    • Lubbock, Texas, United States, 79410
      • 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.
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • 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.
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • 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.
  • Washington
    • Seattle, Washington, United States, 98104
      • 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.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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: Gemzar; LY188011; 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
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	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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.	Baseline to measured progressive disease or death up to 82 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Response (Response Rate)	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).	Baseline to measured progressive disease up to 82 months
Time to Treatment Failure	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.	Baseline to stopping treatment up to 82 months
Overall Survival	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.	Baseline to death from any cause up to 82 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): March 4, 2011
• Last Update Submitted That Met QC Criteria: February 28, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Urogenital Neoplasms; Neoplasms by Site; Peritoneal Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Pelvic Neoplasms; Genital Neoplasms, Female; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Carboplatin; Paclitaxel
• Other Study ID Numbers: 6891; B9E-US-S302 (Other Identifier: Eli Lilly and Company)