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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00047632 |
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 |
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | GIOV-001 |
Study First Received: | October 9, 2002 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00047632 |
Health Authority: | United States: Food and Drug Administration |
ovarian carcinoma peritoneal |
cancer ovary interferon gamma |
Ovarian cancer Ovarian Neoplasms Interferon Type II Gonadal Disorders Interferons Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin |
Ovarian Diseases Ovarian epithelial cancer Carcinoma Genital Diseases, Female Paclitaxel Endocrinopathy Interferon-gamma, Recombinant Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Anti-Infective Agents Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antiviral Agents Pharmacologic Actions Adnexal Diseases |