Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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Docetaxel

Imatinib Mesylate

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Gleevec + Docetaxel: Daily Oral Gleevec in Combination with Every-Three-Week Intravenous Docetaxel

Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV

Gleevec

Leonard J Appleman, MD

The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.

This is a non-randomized multicenter Phase II trial of Gleevec and docetaxel in chemo naïve metastatic hormone refractory prostate cancer. The primary objective of this study is to assess the time to disease progression in patients with hormone refractory prostate cancer treated with daily oral imatinib and intravenous docetaxel, administered every three weeks. Secondary objectives include: 1) to assess the rate of response to imatinib and docetaxel, using Prostate Specific Antigen (PSA) and/or measurable disease; 2) to assess the overall survival of patients with hormone refractory prostate cancer treated with imatinib and docetaxel; and 3) to evaluate the qualitative and quantitative toxicities of this combination.

A Study of Imatinib and Docetaxel in Prostate Cancer

A Phase II Study of Imatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

TTP is the amount of time from date of registration to date of first documentation of progression or symptomatic deterioration. For progression, one or more of the following must occur: (1) 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. (2) Increase in PSA by at least 25% from baseline in patients whose PSA did not decrease, and of 50% from nadir in patients whose PSA decreased with a confirmation 3 weeks later. (3) Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). (4) Appearance of any new lesion/site. (5) Death due to disease without prior documentation of progression and without symptomatic deterioration, which is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

PSA response rate is the number of participants who experienced a best response of: complete response, CR (PSA less than or equal to 0.2 ng/mL, documented two or more times, a minimum of four weeks apart), partial response, PR (a decline in PSA by at least 50%, confirmed by a second PSA value four or more weeks later) or stable disease (does not qualify for CR, PR, Progression or Symptomatic Deterioration, at least 6 weeks after registration) / total number of analyzable patients.

OS is the amount of time in months from the date of registration to the date of death from any cause.

Novartis Pharmaceuticals

Leonard Appleman

Patients with hormone refractory prostate cancer treated with Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days

Hormone Refractory Prostate Cancer Patients

Docetaxel 60 mg/m\^2 IV every 21 days + Imatinib 400 mg PO daily, or, for 10/21 days

Age, Continuous

Sex: Female, Male

Leonard J. Appleman, MD, PhD

Patients with hormone refractory prostate cancer who received at least 1 cycle of Docetaxel + Imatinib

Spots Global Cancer Trial Database for A Study of Imatinib and Docetaxel in Prostate Cancer

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