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A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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 HopeLos Angeles, California  91010
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of California Davis Cancer CenterSacramento, California  95817