Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023894
• Other study ID #: CDR0000068874
• Secondary ID: GOG-0129M
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: June 20, 2013
• Start date: July 2001
• Est. completion date: February 2006

Study information

• Verified date: May 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• alvocidib

Locations

Country	Name	City	State
Australia	Australia New Zealand Gynaecological Oncology Trials Group	Camperdown	New South Wales
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Norway	Norwegian Radium Hospital	Oslo
United Kingdom	University of Birmingham	Birmingham	England
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tuft-New England Medical Center	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Texas Medical Branch	Galveston	Texas
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CCOP - M.D. Anderson Research Base	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	North Shore University Hospital	Manhasset	New York
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	Tacoma General Hospital	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Norway,  United Kingdom, 

References & Publications (1)

Grendys EC Jr, Blessing JA, Burger R, Hoffman J. A phase II evaluation of flavopiridol as second-line chemotherapy of endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):249-53. — View Citation