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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003127
First received: November 1, 1999
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: amifostine trihydrate
Drug: carboplatin
Drug: paclitaxel
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 57
Study Start Date: February 1998
Study Completion Date: July 2004
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carbo, taxol, amifostine
carbo, taxol, amifostine
Drug: amifostine trihydrate
740 mg/m2 IV, Day 1, q 28 days X 6 cycles
Other Name: ethyol
Drug: carboplatin
target AUC=6, IV Day 1, q 28 days X 6 cycles
Other Name: carbo
Drug: paclitaxel
175 mg/m2, IV, Day 1 q 28 days X 6 cycles
Other Name: Taxol

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic, recurrent, or refractory epithelial endometrial carcinoma Must be one of the following histologic types: Endometrioid adenocarcinoma Villoglandular Secretory Ciliated Endometrioid adenocarcinoma with squamous differentiation Serous carcinoma Clear cell carcinoma Mucinous carcinoma Squamous carcinoma Mixed types of carcinoma Undifferentiated carcinoma Must not be amenable to surgery or radiotherapy Documented evidence of progression at site if the only site of measurable disease has been irradiated Metastatic sites need not be biopsied Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 25 mL/min Other: At least 5 years since other prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No more than 1 prior biologic therapy regimen Chemotherapy: No concurrent chemotherapy No prior taxane for any reason No more than 2 prior chemotherapy courses used for the sole purpose of radiosensitization during primary definitive therapy allowed No other prior chemotherapy Endocrine therapy: No concurrent hormonal therapy Prior hormonal or other endocrine therapy allowed Radiotherapy: No concurrent radiotherapy except to sites of bone metastases for palliative control of pain Prior radiotherapy to no more than 30% of bone marrow allowed At least 4 weeks since radiotherapy and recovered Surgery: Prior surgery allowed Must have recovered from surgery and any complication therefrom

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003127

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
University of California Davis Medical Center
Sacramento, California, United States, 95817
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13210
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Kettering, Ohio, United States, 45429
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1329
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79423
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Sidney A. Scudder, MD University of California, Davis
  More Information

Additional Information:
Publications:
Scudder SA, Liu PY, Smith HO, et al.: Paclitaxel (PCT) and carboplatin (C) with amifostine (A) in advanced or recurrent endometrial cancer: a Southwest Oncology Group trial (S9720). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-819, 2001.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003127     History of Changes
Other Study ID Numbers: CDR0000065890, SWOG-S9720, U10CA032102
Study First Received: November 1, 1999
Last Updated: June 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
stage IV endometrial carcinoma
recurrent endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial clear cell carcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Amifostine
Carboplatin
Paclitaxel
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014