Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: alvocidib

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 1450
      • Australia New Zealand Gynaecological Oncology Trials Group
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center - Calgary
• Norway
  • Oslo, Norway, N-0310
    • Norwegian Radium Hospital
• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B15 2TT
      • University of Birmingham
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
      • University of Alabama at Birmingham Comprehensive Cancer Center
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Gatos, California, United States, 95032
      • Community Hospital of Los Gatos
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
  • Colorado
    • Denver, Colorado, United States, 80010
      • University of Colorado Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center
  • Florida
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60612-3864
      • Rush-Presbyterian-St. Luke's Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5289
      • Indiana University Cancer Center
  • Iowa
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0084
      • Albert B. Chandler Medical Center, University of Kentucky
  • Maryland
    • Bethesda, Maryland, United States, 20892-1182
      • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tuft-New England Medical Center
    • Worcester, Massachusetts, United States, 01605-2982
      • University of Massachusetts Memorial Medical Center - University Campus
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Cancer Center
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic Cancer Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
    • Keesler AFB, Mississippi, United States, 39534-2576
      • Keesler Medical Center - Keesler AFB
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center - Columbia
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Camden, New Jersey, United States, 08103-1489
      • Cooper Hospital/University Medical Center
  • New York
    • Brooklyn, New York, United States, 11203
      • State University of New York Health Science Center at Brooklyn
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • Stony Brook, New York, United States, 11794-8091
      • State University of New York Health Sciences Center - Stony Brook
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center, UNC
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Winston-Salem, North Carolina, United States, 27157-1065
      • Comprehensive Cancer Center at Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0526
      • Barrett Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43210-1240
      • Arthur G. James Cancer Hospital - Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma College of Medicine
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001-3788
      • Abington Memorial Hospital
    • Hershey, Pennsylvania, United States, 17033-0850
      • Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Pennsylvania Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107-5541
      • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 29425-2233
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brookview Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75390-9032
      • Simmons Cancer Center - Dallas
    • Galveston, Texas, United States, 77555-0587
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • Houston, Texas, United States, 77030-4009
      • CCOP - M.D. Anderson Research Base
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care - Medical Center Campus
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center
    • Tacoma, Washington, United States, 98405
      • Tacoma General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Edward C. Grendys, MD, Robert H. Lurie Cancer Center

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.ygyno.2005.05.017.

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: September 13, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: May 1, 2004

More Information

Terms related to this study

• Keywords: recurrent endometrial carcinoma
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Alvocidib
• Other Study ID Numbers: CDR0000068874; GOG-0129M