Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer

October 30, 2007 updated by: InterMune

Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.

The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the progression or return of cancer; 3) the effects on quality of life; and 4) the safety of interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Approximately 800 patients will receive either chemotherapy alone or chemotherapy plus Interferon gamma-1b. Chemotherapy will be paclitaxel (175 mg/m2 over 3 hours) followed by carboplatin (AUC 6) every 3 weeks. Only those patients in the treatment arm will receive interferon doses. Interferon gamma-1b 100 mg will be administered subcutaneously 3 times per week (every other day; no more than 3 doses in a 7-day period) continuously while patients are treated with carboplatin / paclitaxel (including for the 3 weeks following the last dose of chemotherapy). A total of 6 cycles of chemotherapy will be given unless disease progression or liming toxicity occurs or patients refuse further treatment. Each patient will receive a total of 54 doses over a period of 18 weeks. Each patient's participation will be from 3-8 years in duration.

Study Type

Interventional

Enrollment (Actual)

847

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Brisbane, California, United States, 94005
        • InterMune, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO Stage III or IV disease. Patients with either optimal (<= 1 cm residual disease) or suboptimal residual disease following initial surgery are eligible. Unstained slides of the primary tumor, a primary tumor block, or cytological preparation must be available for review.
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
  • <= 12 weeks after initial surgery with adequate recovery from surgery.
  • Candidate for first-line chemotherapy
  • Adequate bone marrow function (ANC >= 1,500/mL; platelets >= 100,000/mL; hemoglobin >= 10 gm/dL)
  • Adequate hepatic function (AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal; bilirubin <= 1.5 x upper limit of normal).
  • Adequate renal function (creatinine <= 1.5 x upper limit of normal).
  • Adequate neurologic function (sensory and motor neuropathy <= NCI CTC Grade 1).
  • Negative urine pregnancy test in women of child-bearing potential (within 14 days of the initiation of the first chemotherapy cycle).
  • Zubrod / ECOG / GOG performance score 0-2.
  • Able to give informed consent.

Exclusion criteria:

  • Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If diagnosis is based on cytology alone [(e.g., fine needle aspiration (FNA)], slides must be available, and confounding carcinomas such as non-ovarian mucinous, colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be ruled out.
  • Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical debulking.
  • Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to protocol therapy is planned.
  • Prior biological response modifier (BRM) for any reason within the previous 5 years.
  • Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy > 5 years previously may be eligible for this trial if they have not received any anti-neoplastic treatment within the previous 5 years an dif they have been without any evidence of disease for the previous 5 years.
  • Uncontrolled infection.
  • Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the dosing portion of the study.
  • Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival time assessed at end of study
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival time assessed at interim analysis
Time Frame: 4 years
4 years
Treatment failure-free survival time assessed at end of study
Time Frame: 4 years
4 years
Quality of life assessed through 24 months after end of treatment
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InterMune

Investigators

  • InterMune, Inc. 888-486-6411, Medical Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

October 9, 2002

First Submitted That Met QC Criteria

October 10, 2002

First Posted (Estimate)

October 11, 2002

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIOV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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