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

Phase 2

Completed

• Conditions: Endometrial Cancer
• Interventions: Drug: amifostine trihydrate; Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT00003127
• Lead Sponsor: SWOG Cancer Research Network

Brief 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.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-04
• Study First Submitted QC: 2004-06-23
• Study First Posted: 2004-06-24
• Study Completion: 2004-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carbo, taxol, amifostine	amifostine trihydrate	carbo, taxol, amifostine
carbo, taxol, amifostine	carboplatin	carbo, taxol, amifostine
carbo, taxol, amifostine	paclitaxel	carbo, taxol, amifostine

Primary Outcome Measures

Name	Time	Method
Progression free survival	6 months	from date of registration to date of first observation of progressive disease, deathe due to any cause, or early discontinuation of treatment.

Secondary Outcome Measures

Name	Time	Method
overall survival	6 months	From date of registration to date of death due to any cause
response	after 12 and 24 weeks	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	Weekly X 3, q 4 weeks X 6 cycles	assessment per SWOG toxicity criteria

Trial Locations

Locations (94)

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan); 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Long Beach; 🇺🇸 Long Beach, California, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

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