Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Overall survival time assessed at end of study
4 years
InterMune, Inc. 888-486-6411
Medical Information
United States: Food and Drug Administration
GIOV-001
NCT00047632
October 2001
February 2006
Name | Location |
---|---|
InterMune, Inc. | Brisbane, California 94005 |