Chemotherapy in Treating Patients Who Have Metastatic Prostate Cancer

NCT00003343 | Completed Phase 3

• 2 other identifiers: AG-3340-009CDR0000066320
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether mitoxantrone and prednisone are more effective with or without prinomastat in treating patients with metastatic prostate cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of mitoxantrone and prednisone with or without prinomastat in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer

Interventions

endocrine-modulating drug therapy DRUG

mitoxantrone hydrochloride DRUG

prednisone DRUG

prinomastat DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic, hormone refractory prostate cancer Must have undergone prior orchiectomy or treatment with an LHRH analog Prior treatment with an antiandrogen agent (e.g., flutamide or bicalutamide) is optional Castrate serum testosterone no greater than 50 ng/mL PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Not specified Other: Effective contraception is required of all patients For more information regarding this protocol, please call 1-888-849-6482. Clinical sites are throughout the United States and Canada. PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for prostate cancer Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: See Disease Characteristics At least 6 weeks since bicalutamide At least 4 weeks since flutamide Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Agouron Pharmaceuticals, Inc.

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mitoxantrone; Prednisone; prinomastat

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Mary Collier

  Agouron Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 16, 2004
• Study Start: March 1, 1998
• Primary Completion: January 1, 2001
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

US (1)