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

NCT00064610 | Completed Phase 1

• 1 other identifier: M34101-033
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostatic Neoplasms

Keywords

Advanced androgen-independent prostate cancer

Interventions

VELCADE TM (bortezomib) for Injection DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patient has a history of allergic reactions to diuretics or anti-emetics suggested to be administered in conjunction with study drug
• Patient has a history of severe hypersensitivity reaction to docetaxel or other agents formulated with polysorbate 80.
• Patient had a myocardial infarction within six months of enrollment or has uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia
• Patient has uncontrolled brain metastases or central nervous system disease.
• Patient has Grade 2 or higher peripheral neuropathy
• Patient has any of the following pretreatment laboratory data within 14 days before the first study drug dose:
• Total bilirubin \> than the upper limit of normal (ULN).
• Alanine transaminase (ALT) and/or aspartate transaminase (AST) \>1.5 x the ULN concurrent with alkaline phosphatase \>2.5 x the ULN.
• Alkaline phosphatase \>5 x the ULN, unless shown by fractionation to be bone-derived and AST, ALT, bilirubin, gamma glutamyl transferase (GGT), and 5'nucleotidase are \<1.5 x the ULN and bilirubin is within normal range.
• Serum testosterone 50 ng/mL or higher.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (4)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Columbia-Presbyterian Hospital

New York, New York, 10032, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bortezomib; WW Domain-Containing Oxidoreductase

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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2003
• First Posted: July 11, 2003
• Study Start: December 1, 2002
• Primary Completion: December 1, 2004
• Last Updated: February 11, 2008

Record last verified: 2008-02

Locations

US (4)