Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT00003691|
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : July 9, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel||Phase 3|
- Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma.
- Compare the toxicities of these two regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days.
Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Official Title:||A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma|
|Study Start Date :||December 1998|
|Primary Completion Date :||June 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003691
Show 73 Study Locations
|Study Chair:||Gini F. Fleming, MD||University of Chicago|