Chemotherapy in Treating Patients Who Have Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003343
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : August 8, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: endocrine-modulating drug therapy Drug: mitoxantrone hydrochloride Drug: prednisone Drug: prinomastat Phase 3

Detailed Description:

OBJECTIVES: I. Compare symptomatic progression free survival among patients having metastatic, hormone refractory prostate cancer receiving one of two doses of matrix metalloprotease inhibitor AG3340 or placebo initially in combination with mitoxantrone and prednisone with provision for subsequent change in therapy. II. Compare the symptomatic response, quality of life, serologic (PSA) response, PSA progression free survival, radiographic response, radiographic progression free survival, one year survival, and overall survival of these patients. III. Evaluate the safety of AG3340 in regimen combination and in combination with therapies administered subsequent to first line in this patient population. IV. Evaluate the population pharmacokinetics of AG3340 when given in this treatment regimen.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive the matrix metalloprotease inhibitor AG3340 (at one of two dosages) or placebo, orally twice a day, beginning on day 1. Patients receive mitoxantrone by intravenous infusion on day 1 and prednisone orally twice daily beginning on day 1. Treatment course is repeated every 3 weeks in the absence of unacceptable toxicity. Mitoxantrone and/or prednisone may be discontinued or switched at the investigator's discretion.

PROJECTED ACCRUAL: There will be 525 patients accrued into this study from approximately 50 centers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor AG3340 in Combination With Mitoxantrone and Prednisone With Provision for Subsequent Change in Therapy in Patients Having Hormone-Refractory Prostate Cancer
Study Start Date : March 1998
Actual Primary Completion Date : January 2001

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003343

United States, California
Agouron Pharmaceuticals, Inc.
La Jolla, California, United States, 92037
Sponsors and Collaborators
Study Chair: Mary Collier Agouron Pharmaceuticals

Responsible Party: Pfizer Identifier: NCT00003343     History of Changes
Other Study ID Numbers: AG-3340-009
First Posted: July 16, 2004    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Pfizer:
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Matrix Metalloproteinase Inhibitors
Protease Inhibitors