Trials / Completed
CompletedNCT00002894
Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Medical Research Council · Other Government
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | |
| DRUG | cisplatin | |
| DRUG | paclitaxel |
Timeline
- Start date
- 1996-03-01
- Completion
- 2003-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-12-19
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00002894. Inclusion in this directory is not an endorsement.