Clinical trial NCT00003256: Flavopiridol in Treating Patients With Recurrent Prostate Cancer
Official title: A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IV prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-02
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Beckman Research Institute, City of Hope
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: George Wilding, MD
role: STUDY_CHAIR
References:
citation: 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.