Trials / Terminated
TerminatedNCT00047632
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 847 (actual)
- Sponsor
- InterMune · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Interferon gamma-1b | 100 mcg, SQ, 3x per week |
Timeline
- Start date
- 2001-10-01
- Completion
- 2006-02-01
- First posted
- 2002-10-11
- Last updated
- 2007-11-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00047632. Inclusion in this directory is not an endorsement.