Flavopiridol in Treating Patients With Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003256
• Other study ID #: CDR0000066145
• Secondary ID: WCCC-CO-9781NCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 8, 2013
• Start date: May 1998
• Est. completion date: April 2004

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2004
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• alvocidib

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Beckman Research Institute, City of Hope	Duarte	California
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	University of California Davis Cancer Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Liu G, Gandara DR, Lara PN Jr, Raghavan D, Doroshow JH, Twardowski P, Kantoff P, Oh W, Kim K, Wilding G. A Phase II trial of flavopiridol (NSC #649890) in patients with previously untreated metastatic androgen-independent prostate cancer. Clin Cancer Res. — View Citation