Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004876
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2000-03-07
Brief Title:
Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study Comparing Carboplatin and Thalidomide With Carboplatin Alone in Patients With Stage Ic - IV Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2011-11
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 Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor
PURPOSE This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer
PURPOSE This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer
Determine the antiangiogenic effect of thalidomide in this patient population
Compare the efficacy of carboplatin with or without thalidomide in this patient population
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive carboplatin IV over 1 hour Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive carboplatin as in arm I Patients receive thalidomide orally once daily Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer
Determine the antiangiogenic effect of thalidomide in this patient population
Compare the efficacy of carboplatin with or without thalidomide in this patient population
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive carboplatin IV over 1 hour Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive carboplatin as in arm I Patients receive thalidomide orally once daily Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99018 | None | None | None |
| ICRF-96084 | None | None | None |