Clinical trial NCT00176293 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: dexamethasone, doxorubicin
SMILES: C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with metastatic hormone refractory prostate cancer as defined by resistance
             to both ablative therapy (with either LHRH agonists or orchiectomy) & anti-androgens.

          2. Patients must have symptoms related to disease.

          3. Patients must have PS 0,1,2 (ECOG).

          4. Patients must have measurable disease (RECIST) or PSA > 5.

          5. Patients must have adequate organ function as defined as follows: leukocytes >/=
             3,000/mm3, absolute neutrophil count >/= 1,500/mm3, hemoglobin >/= 8.0g/dl, platelets
             >/= 100,000/mm3, serum creatinine </= 2.5 mg/dl. Bilirubin must be </= 2 fold above
             ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if
             alkaline phosphatase is </= ULN or alkaline phosphatase may be up to 4 x ULN if
             transaminases are </= ULN.

          6. Patients must have a left ventricular ejection fraction (LVEF) 50% by echocardiogram

          7. Patients must have failed to respond to discontinuation of anti-androgens.

          8. No previous therapy with anti-androgens, corticosteroids or estrogens in the last 4
             weeks.

          9. Previous radiation therapy is allowed if completed at least 4 weeks prior to study
             entry & therapy was cumulatively administered to </= 25% of bone marrow.

         10. Patients must be >18 years of age

         11. Patients must have an expected survival of at least 4 months.

         12. Patients must have the ability to understand & the willingness to sign a written
             informed consent document.

         13. Patients must be willing to use adequate contraceptive method during treatment and for
             3 months after completing treatment.

        Exclusion Criteria:

          1. Patients with previous history of cancer are excluded unless they have had curative
             treatment completed >/= 5 years prior to entry onto study or had 1 of the following:
             in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous
             cell carcinoma of the skin.

          2. Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations
             that would limit compliance with study requirements or the ability to provide informed
             consent.

          3. Patients requiring any non study corticosteroids for any reason are excluded.

          4. Patients who have received previous chemotherapy.

          5. A history of cardiac disease with New York Heart Class II or greater, or clinical
             evidence of congestive heart failure.

          6. Patients may not be receiving any other investigational agents or have participated in
             any investigational drug study within 4 weeks preceding initiation of treatment.

          7. Major surgery within 4 weeks prior to study treatment start, or lack of complete
             recovery from major surgery.

          8. Patients with a lack of physical integrity of the upper gastrointestinal tract or
             those who have malabsorption syndrome or inability to swallow tablets.

          9. History of hypersensitivity reactions attributed to a conventional formulation of
             doxorubicin HCL or the components of Doxil®