Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003880
Status:
TERMINATED
Last Update Posted:
2015-04-16
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Carboplatin With or Without SCH-58500 in Treating Patients With Newly Diagnosed Stage III Ovarian or Stage III Primary Peritoneal Cancer
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase IIIII Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH 58500 in Newly Diagnosed Stage III Ovarian and Primary Peritoneal Cancer Patients With Greater Than or Equal to 05 cm and Less Than or Equal to 2 cm Residual Disease Following Surgery
Status:
TERMINATED
Status Verified Date:
2015-04
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 chemotherapy with gene therapy using SCH-58500 may kill more tumor cells
PURPOSE Randomized phase IIIII trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor
PURPOSE Randomized phase IIIII trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor
Detailed Description:
OBJECTIVES I Assess the effect of paclitaxel and carboplatin with or without SCH 58500 on progression free survival overall survival safety response and CA-125 levels in patients with newly diagnosed stage III ovarian epithelial or primary peritoneal cancer
OUTLINE This is a randomized open label multicenter study Patients receive treatment of IV paclitaxel and IV carboplatin Patients are randomized to one of two treatment groups Arm I Patients receive IV paclitaxel over 3 hours immediately followed by IV carboplatin on day 1 Courses are repeated every 21 days Arm II Patients receive IV paclitaxel over 3 hours immediately followed by IV carboplatin on day 1 Patients receive intraperitoneal SCH 58500 on days 1-5 Courses are repeated every 21 days Patients are followed every 6 weeks for 36 months then every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 360 patients 180 per treatment arm will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients receive treatment of IV paclitaxel and IV carboplatin Patients are randomized to one of two treatment groups Arm I Patients receive IV paclitaxel over 3 hours immediately followed by IV carboplatin on day 1 Courses are repeated every 21 days Arm II Patients receive IV paclitaxel over 3 hours immediately followed by IV carboplatin on day 1 Patients receive intraperitoneal SCH 58500 on days 1-5 Courses are repeated every 21 days Patients are followed every 6 weeks for 36 months then every 3 months for 2 years and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 360 patients 180 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| SPRI-CI98-102 | None | None | None |
| SPRI-C98-102 | None | None | None |
| NCI-V99-1544 | None | None | None |
| CDR0000067047 | None | None | None |