S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer
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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory endometrial cancer.
Drug: amifostine trihydrate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma|
- Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.
- overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]From date of registration to date of death due to any cause
- response [ Time Frame: after 12 and 24 weeks ] [ Designated as safety issue: No ]Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No disease progression. No new lesions.
- toxicity [ Time Frame: Weekly X 3, q 4 weeks X 6 cycles ] [ Designated as safety issue: Yes ]assessment per SWOG toxicity criteria
|Study Start Date:||February 1998|
|Study Completion Date:||July 2004|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
Experimental: carbo, taxol, amifostine
carbo, taxol, amifostine
Drug: amifostine trihydrate
740 mg/m2 IV, Day 1, q 28 days X 6 cycles
Other Name: ethyolDrug: carboplatin
target AUC=6, IV Day 1, q 28 days X 6 cycles
Other Name: carboDrug: paclitaxel
175 mg/m2, IV, Day 1 q 28 days X 6 cycles
Other Name: Taxol
OBJECTIVES: I. Evaluate the efficacy of paclitaxel and carboplatin with amifostine on progression free survival and overall survival in patients with metastatic or recurrent epithelial endometrial carcinoma not amenable to surgery or radiotherapy. II. Evaluate response (confirmed and unconfirmed partial response and complete response) rate to this regimen in this patient population. III. Assess the nature and degree of toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours, then amifostine IV over 10 minutes, followed fifteen minutes later by carboplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days. Treatment continues for 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 35 to 50 patients will be accrued for this study.