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A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Phase 2
Not Enrolling
Endometrial Cancer

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Trial Information

A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


- Determine the antitumor activity of flavopiridol in patients with recurrent or
persistent endometrial carcinoma.

- Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days
for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24

Inclusion Criteria


- Histologically confirmed primary endometrial carcinoma

- Recurrent or persistent disease

- Refractory to curative therapy or established treatment

- Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single
agent or combination therapy) for endometrial carcinoma

- Initial treatment may include high-dose, consolidation, or extended therapy
administered after surgical or non-surgical assessment

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- At least 1 target lesion outside previously irradiated field

- Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as
any active GOG phase III protocol for the same patient population



- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- PT/PTT normal


- Creatinine no greater than 1.5 times ULN


- No prior thromboembolic events or thrombophlebitis

- No prior recent myocardial infarction

- No prior angina

- No prior cerebrovascular accident

- No prior transient ischemic attacks


- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- No grade 2 or greater sensory or motor neuropathy

- No active infection requiring antibiotics


Biologic therapy:

- At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma


- See Disease Characteristics

- At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered

Endocrine therapy:

- At least 1 week since prior hormonal therapy for endometrial carcinoma

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered


- At least 3 weeks since prior surgery for endometrial carcinoma and recovered

- At least 6 months since prior re-vascularization procedures (e.g., coronary artery
bypass graft, carotid endarterectomy or bypass, or angioplasty with or without


- At least 3 weeks since other prior therapy for endometrial carcinoma

- At least 6 months since prior thrombolytic procedures

- No prior cyclin-dependent kinase inhibitors

- No prior anticancer therapy that would preclude study

- No concurrent amifostine or other protective reagents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Edward C. Grendys, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

February 2006

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Tacoma General Hospital Tacoma, Washington  98405
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Community Hospital of Los Gatos Los Gatos, California  95032
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Brookview Research, Inc. Nashville, Tennessee  37203
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
University of Texas Medical Branch Galveston, Texas  77555-1329
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Tuft-New England Medical Center Boston, Massachusetts  02111
Barrett Cancer Center Cincinnati, Ohio  45267-0502
Fletcher Allen Health Care - Medical Center Campus Burlington, Vermont  05401
CCOP - M.D. Anderson Research Base Houston, Texas  77030-4009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182