Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer.
Drug: doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Trial Of Doxorubicin/Cisplatin/Paclitaxel And G-CSF Versus Carboplatin/Paclitaxel In Patients With Stage III & IV Or Recurrent Endometrial Cancer|
- Duration of overall survival [ Designated as safety issue: No ]
- Duration of progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Estimated Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Given by injectionDrug: cisplatin
Given IVDrug: doxorubicin hydrochloride
Given IVDrug: paclitaxel
Experimental: Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Given IVDrug: paclitaxel
- Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer.
- Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens.
- Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients accrued as of 04/17/06 are stratified according to disease status(measurable or recurrent disease vs non-measurable stage III or IV disease with pelvic radiotherapy vs non-measurable stage III or IV disease without pelvic radiotherapy). Patients are randomized to 1 of 2 treatment arms. Patients with LVEF < 50% at randomization who are initially randomized to arm I are immediately crossed over to arm II.
- Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1.
In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063999
Show 505 Study Locations
|Study Chair:||David S. Miller, MD||Simmons Cancer Center|