Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

NCT00085332 | Completed Phase 2 DMC

• 2 other identifiers: GOG-0129NCDR0000368634
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 75

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

Conditions

Endometrial Cancer

Keywords

recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma

Interventions

docetaxel DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed endometrial carcinoma * Recurrent or persistent disease * Refractory to curative or standard therapy * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are not considered target lesions * Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment * One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction * Ineligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age * Any age Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No neuropathy (sensory and motor) ≥ grade 2 * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 3 weeks since prior biologic or immunologic therapy for malignant tumor * No concurrent prophylactic growth factors * No concurrent prophylactic thrombopoietic agents Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs) Endocrine therapy * At least 1 week since prior hormonal therapy for malignant tumor * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy Surgery * Recovered from prior surgery Other * At least 3 weeks since other prior therapy for malignant tumor * No prior anticancer therapy that would preclude current protocol therapy * No concurrent amifostine or other protective reagents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (75)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1740, United States

Location

Women's Cancer Center - Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612-3824, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62794-9640, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Cancer Center at Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01605-2982, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital

Camden, New Jersey, 08103-1489, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11790-7775, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7570, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Gynecologic Oncology Network

Greenville, North Carolina, 27858, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0520, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44124, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73104, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Southeast Gynecologic Oncology Associates

Knoxville, Tennessee, 37917, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9032, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

Burlington, Vermont, 05401, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6188, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Australia New Zealand Gynaecological Oncology Trials Group

Camperdown, New South Wales, 1450, Australia

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Kagoshima City Hospital

Kagoshima, 892-8580, Japan

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (1)

• Garcia AA, Blessing JA, Nolte S, Mannel RS; Gynecologic Oncology Group. A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group. Gynecol Oncol. 2008 Oct;111(1):22-6. doi: 10.1016/j.ygyno.2008.06.013.

  PMID: 18675446 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Agustin Garcia, MD

  Premiere Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: July 1, 2004
• Primary Completion: December 1, 2005
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

JP (1); NO (1); AU (1); CA (1); US (71)