NCT00003127

S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer

Phase II Trial of Paclitaxel and Carboplatin With Amifostine in Advanced Recurrent or Refractory Endometrial Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 16 Years
• 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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic, recurrent, or refractory endometrial cancer.

Detailed description

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	amifostine trihydrate	740 mg/m2 IV, Day 1, q 28 days X 6 cycles
DRUG	carboplatin	target AUC=6, IV Day 1, q 28 days X 6 cycles
DRUG	paclitaxel	175 mg/m2, IV, Day 1 q 28 days X 6 cycles

Timeline

• Start date: 1998-02-01
• Primary completion: 2003-04-01
• Completion: 2004-07-01
• First posted: 2004-06-24
• Last updated: 2012-06-14

Locations

94 sites across 1 country: United States