Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023894
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: alvocidib Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date : July 2001
Actual Study Completion Date : February 2006

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 stents)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023894

  Show 54 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center

Publications of Results: Identifier: NCT00023894     History of Changes
Other Study ID Numbers: CDR0000068874
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: May 2004

Keywords provided by National Cancer Institute (NCI):
recurrent endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action