A Study of Imatinib and Docetaxel in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Gleevec; Docetaxel
Intervention description: Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m^2 administered IV; 60 mg/m^2 administered IV on day 0
Intervention MeSH terms: Docetaxel; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have a histologic diagnosis of adenocarcinoma of the prostate Stage D2 that is
             unresponsive or refractory to hormone therapy. Must have metastatic prostate cancer
             with a rising PSA, and deemed to be hormone refractory.

          2. All subjects must have pre-study PSA within 28 days prior to registration

          3. Subjects who have measurable disease must have had X-rays, scans or physical
             examinations used for tumor measurement completed within 28 days prior to
             registration. Subjects must have non-measurable disease assessed within 28 days (for
             PSA level) or 42 days (for imaging studies) prior to registration.

          4. Subjects with bone metastases, as documented by X-ray, bone scan, MRI, or biopsy.

          5. All subjects must have had a CT scan of the abdomen and pelvis within 28 days prior to
             registration.

          6. Subjects must have been surgically or medically castrated. If the method of castration
             was LHRH (Luteinizing Hormone-Releasing Hormone) agonists, then the subject must be
             willing to continue the use of LHRH agonists.

          7. If the subject has been treated with non-steroidal anti-androgens or other hormonal
             treatment these agents must have been stopped at least 28 days prior to enrollment for
             flutamide or ketoconazole, and at least 42 days prior to enrollment for bicalutamide
             or nilutamide; and the subjects must have demonstrated progression of disease since
             the agents were suspended.

          8. Prior radiation therapy is allowed. At least 21 days must have elapsed since the
             completion of radiation therapy, and the subject must have recovered from the side
             effects of the radiation

          9. 9. Due to the unknown side effects of imatinib, men of reproductive potential must
             agree to use an effective contraceptive method.

         10. Subjects must have recovered from major infections and/or surgical procedures and, in
             the opinion of the investigator, not have significant active concurrent other medical
             illness precluding protocol treatment.

         11. ECOG performance status of 0-1

         12. ANC ≥ 1,500/mL and a platelet count of ³ 100,000/mL. These tests must be obtained
             within 7 days prior to registration.

         13. Serum bilirubin ≤ 1.3, SGOT and SGPT ≤ 2 x institutional upper limit of normal, and a
             serum creatinine ≤ 1.8 mg/dl. These tests must be obtained within 7 days prior to
             registration. Testosterone level may be done 28 days prior to study entry.
             Testosterone level should be below 50 ng/dL.

        Exclusion Criteria:

          1. No prior chemotherapy for hormone-refractory disease is allowed. At least three weeks
             must have elapsed since the completion of any non-cytotoxic investigational therapy,
             and the patient must have recovered from the side effects of the therapy.

          2. No other cytotoxics, biological response modifiers, radiation therapy, corticosteroid
             or hormonal concomitant therapy (other than continuing LHRH treatment) may be given
             during protocol treatment. Bisphosphonates may be given during protocol treatment. No
             unconventional therapy may be given during protocol treatment.

          3. Subjects must NOT have Grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria.

          4. Subjects with known chronic liver disease are NOT eligible

          5. Must NOT have a known diagnosis of human immunodeficiency virus (HIV) infection.

          6. Subjects must NOT have known brain metastases.

          7. No prior malignancy is allowed except for the following: adequately treated basal cell
             or squamous cell skin cancer, in situ carcinoma of any site, adequately treated Stage
             I or II cancer from which the patient is currently in complete remission, or any other
             cancer from which the patient has been disease-free for 5 years.