Flavopiridol in Treating Patients With Recurrent Prostate Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: alvocidib

Study type: Interventional

Funder types: NIH

Identifiers

NCT00003256

CDR0000066145

NCI-T97-0038

WCCC-CO-9781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: alvocidib