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Completed

NCT Number: NCT00003256

Flavopiridol in Treating Patients With Recurrent Prostate Cancer

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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beckman Research Institute, City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alvocidib

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2002
Study completion
2004
First posted
Aug 2, 2004
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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