Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002894
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMISED TRIAL OF PACLITAXEL TAXOL IN COMBINATION WITH PLATINUM CHEMOTHERAPY VS CONVENTIONAL PLATINUM-BASED CHEMOTHERAPY IN THE TREATMENT OF WOMEN WITH RELAPSED OVARIAN CANCER
Status:
COMPLETED
Status Verified Date:
2001-02
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 may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer
PURPOSE Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy
Compare the quality of life and health economics of these regimens in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive platinum-based chemotherapy that is familiar to the oncologist and used routinely by the center comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs
Arm II Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin
Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity
Quality of life is assessed
Patients are followed at 6 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 800 patients will be accrued for this study
Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy
Compare the quality of life and health economics of these regimens in these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
Arm I Patients receive platinum-based chemotherapy that is familiar to the oncologist and used routinely by the center comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs
Arm II Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin
Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity
Quality of life is assessed
Patients are followed at 6 months every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 800 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 |
|---|---|---|---|
| ISRCTN47434271 | None | None | None |
| MRC-ICON4 | None | None | None |
| EU-96051 | None | None | None |