Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047632
Status:
TERMINATED
Last Update Posted:
2007-11-01
First Post:
2002-10-09
Brief Title:
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer
Sponsor:
InterMune
Organization:
InterMune
Study Overview
Official Title:
Interferon Gamma-1b in Combination With Chemotherapy CarboplatinPaclitaxel for First Line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2 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 patients participation will be from 3-8 years in duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None