S9720 Combination Chemotherapy in Treating Patients With Metastatic, Recurrent, or Refractory Endometrial Cancer
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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 |
- 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
| 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 |
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
Hide Study 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 | |
| Study Chair: | Sidney A. Scudder, MD | University of California, Davis |
More Information
Additional Information:
Publications:
| 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 Adenoma 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 |
ClinicalTrials.gov processed this record on May 16, 2013