Completed

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

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What is being tested

alvocidib

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 1998
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003256
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Beckman Research Institute, City of Hope

Duarte, United StatesOpen Beckman Research Institute, City of Hope in Google Maps

University of California Davis Cancer Center

Sacramento, United States

Dana-Farber Cancer Institute

Boston, United States

University of Wisconsin Comprehensive Cancer Center

Madison, United States
Completed4 Study Centers