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Completed

NCT Number: NCT00191646

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

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.

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Key information

Conditions

Genital Neoplasms, Female Abdominal Neoplasms Adnexal Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pelvic Neoplasms Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

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: LY188011, Gemzar

paclitaxel

Drug

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

carboplatin

Drug

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 outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Mar 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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