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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023894 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: alvocidib |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary endometrial carcinoma
Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 54 Study Locations| Study Chair: | Edward C. Grendys, MD | Robert H. Lurie Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00023894 History of Changes |
| Other Study ID Numbers: | CDR0000068874, GOG-0129M |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma |
Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Flavopiridol Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |