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

NCT ID: NCT00047632

Last Updated: 2007-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 847 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2006-02-28

Brief Summary

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.

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.

Conditions

Ovarian Carcinoma; Peritoneal Carcinoma

Keywords

ovarian; carcinoma; peritoneal; cancer; ovary; interferon gamma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Interferon gamma-1b

100 mcg, SQ, 3x per week

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

InterMune

INDUSTRY

Sponsor Role: lead

Principal Investigators

InterMune, Inc. 888-486-6411

Role:

Medical Information

Locations

InterMune, Inc.

Brisbane, California, United States

Countries

United States

Other Identifiers

GIOV-001

Identifier Type: -

Identifier Source: org_study_id