Flavopiridol in Treating Patients With Recurrent Prostate Cancer

NCT00003256 | Completed Phase 2

• 3 other identifiers: CDR0000066145WCCC-CO-9781NCI-T97-0038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IV prostate cancer

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: alvocidib

Interventions

alvocidib DRUG

Arm I

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related 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. 2004 Feb 1;10(3):924-8. doi: 10.1158/1078-0432.ccr-03-0050.

  PMID: 14871968 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• George Wilding, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 2, 2004
• Study Start: May 1, 1998
• Primary Completion: July 1, 2002
• Study Completion: April 1, 2004
• Last Updated: February 11, 2013

Record last verified: 2013-01

Locations

US (4)