A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
OBJECTIVES:
I. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen
independent adenocarcinoma of the prostate.
II. Assess the toxic effects of flavopiridol in this patient population.
OUTLINE:
Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4
courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects
may receive a dose escalation. Patients are followed every 3 months until death.
Inclusion Criteria
PATIENT CHARACTERISTICS:
- Performance Status: ECOG 0-2
- Life Expectancy: At least 3 months
- WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,200/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8 g/dL
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times normal
- Creatinine no greater than 1.5 mg/dL
- Prostate-specific antigen at least 10 ng/mL (if bone only disease)
- No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer
- No serious medical illness
- No cord compression symptoms
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
- No prior suramin therapy
- Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other
concurrent hormonal therapy)
- No prior anti-androgen therapy within 4 weeks of study
- At least 4 weeks since prior radiotherapy
- No prior strontium therapy
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
George Wilding, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000066145
NCT ID:
NCT00003256
Start Date:
May 1998
Completion Date:
April 2004
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
