Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038194
Recruitment Status : Completed
First Posted : May 30, 2002
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: imatinib mesylate Drug: docetaxel Phase 1

Detailed Description:


  1. To define the maximum tolerated dose of weekly docetaxel in combination with fixed-dose oral STI571 in adult men with metastatic androgen-independent prostate cancer (AIPC).
  2. To determine the qualitative and quantitative toxicity of the combination of oral STI571 and docetaxel.
  3. Evaluate PSA modulation with STI571 alone at thirty days in patients with AIPC.
  4. Obtain a preliminary estimate of the response rate in AIPC to the combination of STI571 and docetaxel.
  5. Obtain tissue for correlative science studies (these are optional studies).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
Study Start Date : October 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Imatinib + Docetaxel Drug: imatinib mesylate Drug: docetaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Patients with histologic proof of adenocarcinoma of the prostate and must have progressed on conventional hormonal therapy.
  • Patients must have bone metastases which can be demonstrated by bone scans. Lytic bone lesions should be considered for biopsy if there is a clinical suspicion of histologic conversion to small cell carcinoma.
  • Patients must have evidence of progression of disease. PSA- progression is defined as 2 consecutive increments in PSA (an absolute change of at least 1ng/mL) over 4 weeks. An increase by 25% of the product of bidimensional disease qualifies as progression. An increase in the number of metastatic lesions on bone scan qualifies as progression.
  • All patients must have a minimum PSA of 1ng/ml.
  • Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 8 weeks. If progression is documented as below prior to this time interval, patients are eligible.
  • Patients must have a performance status of < 2 (ECOG).
  • Patients must have an expected survival from cancer or co-morbidity of at least three months.
  • Patients may receive no concurrent chemotherapy, immunotherapy or ketoconazole.
  • Patients should not have received prior chemotherapy or radiation within the last 30 days and no Strontium or Samarium within the last 90 days.
  • Patients must have castrate serum testosterone levels (< 30ng/dl). For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
  • Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3.
  • Patients should have adequate hepatic function defined with a bilirubin of < 1.5 mg/dl and AST/ALT < 2X the upper limits of normal.
  • Patients should have adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine < 1.5 X upper limit of normal.
  • Fully recovered from any previous surgery (at least 4 weeks since major surgery.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. The only approved consent is attached to this protocol.


  • Patients with severe intercurrent infection.
  • Patients whose tumors contain small cell or sarcomatoid elements.
  • Patients with NYHA Class III/IV CHF, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia on ECG.
  • CNS metastases that are uncontrolled.
  • Prior hypersensitivity or dose-limiting toxicity with docetaxel.
  • Oxygen-dependent lung disease
  • Contraindications to corticosteroids.
  • Uncontrolled severe hypertension or uncontrolled diabetes mellitus.
  • Second malignancies (except non-melanoma skin cancer) unless disease-free for 3 years.
  • Overt psychosis or mental disability or otherwise incompetent to give informed consent.
  • Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038194

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038194     History of Changes
Other Study ID Numbers: ID01-271
First Posted: May 30, 2002    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
bone metastasis

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Imatinib Mesylate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs