Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00064610

Run by

Millennium Pharmaceuticals, Inc.

People needed

102

Starts

2002-12-01

Last updated by the study team

2008-02-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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]:
• Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray).
• Progressive bone metastasis [presence of new lesion(s) on a bone scan].
• 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 exclusion criteria are not to be enrolled in the study.
• Patient has received chemotherapy within four weeks, nitrosoureas within six weeks, or antibody therapy within eight weeks of enrollment.
• Patient has received radiation therapy within four weeks of enrollment.
• Patient has not recovered from all toxic effects of previous chemotherapy or radiation or antibody therapy.
• Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment.
• Patient has had any major surgery within four weeks of enrollment.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Columbia-Presbyterian Hospital — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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