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

Phase 3

Terminated

• Conditions: Ovarian Carcinoma; Peritoneal Carcinoma

• Registration Number: NCT00047632
• Lead Sponsor: InterMune

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.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2002-10-09
• Study First Submitted QC: 2002-10-10
• Study First Posted: 2002-10-11
• Study Completion: 2006-02
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 847

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival time assessed at end of study	4 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

InterMune, Inc.; 🇺🇸 Brisbane, California, United States