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| Sponsor: | InterMune |
|---|---|
| Information provided by: | InterMune |
| ClinicalTrials.gov Identifier: | NCT00047632 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Carcinoma Peritoneal Carcinoma |
Drug: Interferon gamma-1b |
Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Interferon Gamma-1b in Combination With Chemotherapy (Carboplatin/Paclitaxel) for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma. |
| Enrollment: | 847 |
| Study Start Date: | October 2001 |
| Study Completion Date: | February 2006 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Study ID Numbers: | GIOV-001 |
| Study First Received: | October 9, 2002 |
| Last Updated: | October 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00047632 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian carcinoma peritoneal |
cancer ovary interferon gamma |
|
Anti-Infective Agents Ovarian Neoplasms Neoplasms by Histologic Type Interferon Type II Antineoplastic Agents Gonadal Disorders Interferons Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Antiviral Agents Pharmacologic Actions Carcinoma Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Interferon-gamma, Recombinant Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |