Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003322
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving drugs in different ways may kill more tumor cells It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer
PURPOSE Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer
PURPOSE Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer
Detailed Description:
OBJECTIVES I Compare pathological response recurrence-free interval and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous IV paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal IP cisplatin plus IP paclitaxel II Compare the toxic effects and complications of these 2 treatment regimens in these patients III Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients IV Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma V Compare the quality of life of these patients receiving these treatments
OUTLINE This is a randomized study Patients are stratified according to gross residual disease present vs absent and whether second-look surgery will be performed at the end of treatment yes vs no Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy but after randomization Patients are randomized to one of two treatment arms Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2 Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal IP cisplatin on day 2 plus IP paclitaxel on day 8 Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses Following chemotherapy second look surgery is performed if selected by the patient Quality-of-life assessments are performed prior to randomization prior to course 4 3-6 weeks after the completion of course 6 and prior to second look surgery if selected 6 months after treatment is completed and 12 months after treatment is completed Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL Approximately 384 patients will be accrued for this study within 16 months
OUTLINE This is a randomized study Patients are stratified according to gross residual disease present vs absent and whether second-look surgery will be performed at the end of treatment yes vs no Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy but after randomization Patients are randomized to one of two treatment arms Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2 Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal IP cisplatin on day 2 plus IP paclitaxel on day 8 Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses Following chemotherapy second look surgery is performed if selected by the patient Quality-of-life assessments are performed prior to randomization prior to course 4 3-6 weeks after the completion of course 6 and prior to second look surgery if selected 6 months after treatment is completed and 12 months after treatment is completed Patients are followed every 3 months for 2 years then every 6 months thereafter
PROJECTED ACCRUAL Approximately 384 patients will be accrued for this study within 16 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-0172 | None | None | None |