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

Condition(s) targeted: Endometrial Cancer

Intervention: amifostine trihydrate (Drug); carboplatin (Drug); paclitaxel (Drug); chemotherapy (Procedure)

Phase: Phase 2

Status: No longer recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Sidney A. Scudder, MD, Study Chair, Affiliation: University of California, Davis

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.

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

Study design: Interventional, Treatment

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.

Minimum age: 16 Years. Gender(s): Female.

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

MBCCOP - University of South Alabama, Mobile, Alabama 36688, United States

Arizona Cancer Center, Tucson, Arizona 85724, United States

CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona 85012, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas 72205, United States

Beckman Research Institute, City of Hope, Los Angeles, California 91010, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California 94115-0128, United States

University of California Davis Medical Center, Sacramento, California 95817, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033-0800, United States

Veterans Affairs Medical Center - Long Beach, Long Beach, California 90822, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia 30905-5650, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

Tripler Army Medical Center, Honolulu, Hawaii 96859-5000, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40511-1093, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71130, United States

Boston Medical Center, Boston, Massachusetts 02118, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts 02130, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201, United States

CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0752, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110-0250, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13210, United States

Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Barrett Cancer Center, The University Hospital, Cincinnati, Ohio 45219, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Kettering, Ohio 45429, United States

Cleveland Clinic Cancer Center, Cleveland, Ohio 44195, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma 73104, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Oregon Cancer Center at Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Texas Tech University Health Science Center, Lubbock, Texas 79423, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

University of Texas Medical Branch, Galveston, Texas 77555-1329, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas 75216, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78284, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84132, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Related publications:

Scudder SA, Liu PY, Wilczynski SP, Smith HO, Jiang C, Hallum AV 3rd, Smith GB, Hannigan EV, Markman M, Alberts DS; Southwest Oncology Group. Paclitaxel and carboplatin with amifostine in advanced, recurrent, or refractory endometrial adenocarcinoma: a phase II study of the Southwest Oncology Group. Gynecol Oncol. 2005 Mar;96(3):610-5.

Starting date: February 1998
Last updated: March 5, 2007