Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
| Study Start Date: | July 2004 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the antitumor activity of docetaxel in patients with recurrent or persistent endometrial carcinoma.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arizona | |
| CCOP - Western Regional, Arizona | |
| Phoenix, Arizona, United States, 85006-2726 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1740 | |
| Women's Cancer Center - Los Gatos | |
| Los Gatos, California, United States, 95032 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Hawaii | |
| MBCCOP - Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612-3824 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62794-9640 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1002 | |
| United States, Kentucky | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0084 | |
| United States, Massachusetts | |
| Cancer Center at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01605-2982 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905-0001 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| Keesler Medical Center - Keesler Air Force Base | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65807 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at the Cooper University Hospital | |
| Camden, New Jersey, United States, 08103-1489 | |
| United States, New York | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Long Island Cancer Center at Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11790-7775 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7570 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Gynecologic Oncology Network | |
| Greenville, North Carolina, United States, 27858 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1065 | |
| United States, Ohio | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0520 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44124 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Oklahoma | |
| University of Oklahoma College of Medicine | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001-3788 | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| UPMC Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213-3180 | |
| United States, Tennessee | |
| Southeast Gynecologic Oncology Associates | |
| Knoxville, Tennessee, United States, 37917 | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-2516 | |
| United States, Texas | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390-9032 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0587 | |
| MD Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Vermont | |
| Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6188 | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Australia, New South Wales | |
| Australia New Zealand Gynaecological Oncology Trials Group | |
| Camperdown, New South Wales, Australia, 1450 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Japan | |
| Kagoshima City Hospital | |
| Kagoshima City, Japan, 892-8580 | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Study Chair: | Agustin Garcia, MD | Premiere Oncology |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00085332 History of Changes |
| Other Study ID Numbers: | CDR0000368634, GOG-0129N |
| Study First Received: | June 10, 2004 |
| Last Updated: | February 5, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Endometrial Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female |
Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013