Know Cancer

forgot password

A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


- 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

Inclusion Criteria


- 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

- Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose,
consolidation, or extended therapy administered after surgical or non-surgical

- 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



- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- SGOT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN


- Creatinine ≤ 1.5 times ULN


- 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


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


- See Disease Characteristics

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic

Endocrine therapy

- At least 1 week since prior hormonal therapy for malignant tumor

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- Recovered from prior radiotherapy


- Recovered from prior surgery


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Premiere Oncology


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma



Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Women's Cancer Center - Los Gatos Los Gatos, California  95032
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
Rush University Medical Center Chicago, Illinois  60612-3824
CCOP - Evanston Evanston, Illinois  60201
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Cancer Center at Tufts - New England Medical Center Boston, Massachusetts  02111
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force Base Keesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Cancer Institute of New Jersey at the Cooper University Hospital Camden, New Jersey  08103-1489
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Gynecologic Oncology Network Greenville, North Carolina  27858
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology Associates Knoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus Burlington, Vermont  05401
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
SUNY Downstate Medical Center Brooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390-9063
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
MD Anderson Cancer Center at University of Texas Houston, Texas  77030-4009