Clinical trial NCT00861471 (phase 1/phase 2, status: terminated)
Conditions: prostate cancer, prostatic neoplasms
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, B38.81, N42.31, Z87.430, N40.0, N40.1
Drugs: docetaxel, imatinib mesylate
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Reason stopped: 
    due to slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age.

          -  Histologically documented diagnosis of adenocarcinoma of prostate gland

          -  Patients must have hormone refractory prostate cancer having progressed after at least
             two prior hormonal manipulations with documented castrate levels of testosterone (<50
             ng/dl). PSA ≥ 5 ng/ml

          -  Patients must have hormone-refractory prostate carcinoma as evidenced by PSA
             progression, with or without evidence of measurable disease, or evaluable disease by a
             positive bone scan. PSA progression is defined as > 25% increase in 2 consecutive
             tests in which the first increase in PSA should occur a minimum of 1 week from the
             reference value and this increase in PSA should be confirmed and ≥ 5 ng/ml

          -  Eligible patients will have been treated with at least two prior hormonal
             manipulations including androgen deprivation and may have received one prior
             chemotherapy regimen.

          -  Any chemotherapy, major surgery, or irradiation must have been completed at least 3
             weeks prior to starting study drugs. Patient must have recovered from clinically
             significant toxicities incurred as a result of previous therapy except nail dystrophy,
             alopecia, grade 1 peripheral neuropathy, or radiation therapy induced affects (i.e.,
             impotence or incontinence)

          -  No recent prior flutamide (Eulexin) use within the past 4 weeks, prior bicalutamide
             (Casodex) use within the past 6 weeks, or prior nilutamide (Nilandron) use within the
             past 6 weeks.

          -  Performance status 0,1, 2 (Eastern Cooperative Oncology Group performance status
             scale)

          -  Adequate end organ function, defined as the following:

               -  total bilirubin < 1.5 x upper limit of Normal (ULN)

               -  Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic
                  transaminase (SGPT) < 2.5 x ULN

               -  creatinine < 1.5 x ULN

               -  Absolute Neutrophil count (ANC) > 1.5 x 10^9/L

               -  platelets > 100 x 10^9/L

          -  Written, voluntary informed consent.

          -  Patients must have been and continue to be on androgen deprivation therapy with a
             Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist during study
             participation except for patients who had orchiectomy.

          -  Patients on secondary hormonal manipulation with ketoconazole and hydrocortisone who
             discontinued LHRH therapy must be switched to single agent LHRH analogue therapy
             unless they had orchiectomy.

          -  Patients being treated with Zometa prior to the initiation of the study will be
             permitted to continue with Zometa while on the study.

        Exclusion Criteria:

          -  Patient has received any other investigational agents within 28 days of first day of
             study drug dosing, unless the disease is rapidly progressing.

          -  Patient is < 5 years free of another primary malignancy except: if the other primary
             malignancy is not currently clinically significant nor requiring active intervention,
             or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in
             situ. Existence of any other malignant disease is not allowed.

          -  Patient with Grade III/IV cardiac problems as defined by the New York Heart
             Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6
             months of study)

          -  Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes,
             chronic renal disease, or active uncontrolled infection).

          -  Patient with untreated brain metastasis or cord compression. However, patients with
             treated spinal cord compression or central nervous system (CNS) metastases that have
             been stable are eligible.

          -  Patient has known chronic liver disease (i.e., chronic active hepatitis, and
             cirrhosis).

          -  Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.

          -  Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C)
             prior to study entry, unless the disease is rapidly progressing.

          -  Patient previously received radiotherapy to at least 25 % of the bone marrow

          -  Patient had a major surgery within 2 weeks prior to study entry.

          -  Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent.

          -  If the patient is taking steroids for prostate cancer, then the patient is ineligible
             for this study. If the patient is taking steroids for conditions other than prostate
             cancer, the patient is eligible provided that the reasons for use and dosage are
             documented. The investigator is urged to discuss this issue with the Study Principal
             Investigator for any clarification.

          -  No therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®) will be
             permitted in patients participating in this study.