Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00003644|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 17, 2019
Last Update Posted : June 4, 2019
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. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: carboplatin Drug: paclitaxel||Phase 3|
- Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel.
- Assess the frequency and severity of toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks.
- Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||571 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||March 2010|
Experimental: Carboplatin, paclitaxel, low dose paclitaxel
carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later
Active Comparator: Carboplatin, paclitaxel
- Progression-free Survival [ Time Frame: Up to 5 years ]The percent of participants with disease recurrence within 5 years
- Overall Survival [ Time Frame: up to 96 months ]Number of deaths during study and follow up.
- Number of Participants With Adverse Events Grade 3 or Greater [ Time Frame: Throughout study treatment lasting up to 24 weeks ]Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants
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): NCT00003644
|Study Chair:||Robert S. Mannel, MD||University of Oklahoma College of Medicine|
|Study Chair:||David S. Alberts, MD||University of Arizona|