Prostatic Neoplasms
Conditions
Keywords
Advanced androgen-independent prostate cancer
Brief summary
The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer.
Detailed description
This is a dose escalation study, which means that the first group of patients will receive a low dose of PS-341 (VELCADE) and Docetaxel (Taxotere). If the low dose of VELCADE and Taxotere appears to be safe, then the next group of patients will receive a higher dose of VELCADE and Taxotere.
Interventions
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Patient has histologically-confirmed advanced and/or metastatic androgen-independent prostate cancer requiring anti-neoplastic treatment. * Previous or concurrent hormone therapy with a luteinizing hormone-releasing hormone analog (e.g., leuprolide) does not preclude enrollment in the study. * Patient has progressive measurable or evaluable disease, defined as meeting at least one of the following three criteria \[1\]: 1. Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray). 2. Progressive bone metastasis \[presence of new lesion(s) on a bone scan\]. 3. Progressive PSA, as evidenced by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement. * If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study. * The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be greater than or equal to 5 ng/mL. * Patient is 18 years of age or older. * Patient has a Karnofsky performance status of 60% or greater. * Patient has a life expectancy of three months or longer. * Patient has all of the following pretreatment laboratory data within 14 days before the first study drug dose: * Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3. * Platelets greater than or equal to100,000/mm3. * Hemoglobin \>8.0 g/dL. * Serum creatinine less than or equal to 2.5 mg/dL. * Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care. * Patient agrees to use an acceptable barrier method for contraception from Screening through 90 days after the last study drug dose. \[It is recommended that female partners of male patients enrolled in this study also use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence).\]
Exclusion criteria
Patients meeting any of the following
Countries
United States
Outcome results
None listed