Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00002894|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: carboplatin Drug: cisplatin Drug: paclitaxel||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|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|
|Study Start Date :||March 1996|
|Actual Study Completion Date :||June 2003|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002894
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, WIT 3AA|
|Study Chair:||Jonathan A. Ledermann, MD||University College London Hospitals|