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
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Mary Collier
Investigator Role:
Study Chair
Investigator Affiliation:
Agouron Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
AG-3340-009
NCT ID:
NCT00003343
Start Date:
March 1998
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Agouron Pharmaceuticals, Inc. | La Jolla, California 92037 |
