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Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
This study has been completed.
Study NCT00023894   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: July 23, 2008   History of Changes

September 13, 2001
July 23, 2008
July 2001
 
 
 
Complete list of historical versions of study NCT00023894 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase II
Interventional
Treatment
Endometrial Cancer
Drug: alvocidib
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Norway,   United Kingdom
 
NCT00023894
 
CDR0000068874, GOG-0129M
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP