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


Phase 2
N/A
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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


OBJECTIVES:

- 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
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

- 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

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No prior thromboembolic events or thrombophlebitis

- No prior recent myocardial infarction

- No prior angina

- No prior cerebrovascular accident

- No prior transient ischemic attacks

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

- 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

Radiotherapy:

- See Disease Characteristics

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

Surgery:

- 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
stents)

Other:

- 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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Edward C. Grendys, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068874

NCT ID:

NCT00023894

Start Date:

July 2001

Completion Date:

February 2006

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Tacoma General HospitalTacoma, Washington  98405
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Community Hospital of Los GatosLos Gatos, California  95032
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
University of Texas Medical BranchGalveston, Texas  77555-1329
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Tuft-New England Medical CenterBoston, Massachusetts  02111
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
CCOP - M.D. Anderson Research BaseHouston, Texas  77030-4009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182