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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Notify MeKey information
Conditions
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2
Primary location
Beckman Research Institute, City of Hope, Duarte, California, United States
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
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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