The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism).

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: Amonafide L-malate (drug)	Phase I Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Men 18 years or older;
• Metastatic androgen-independent prostate cancer with evidence of progression;
• Zero or one prior course of chemotherapy for metastatic disease;
• Up to two prior courses of non-cytotoxic therapies for metastatic disease;
• Progressive measurable or assessable disease;
• Evidence of continued elevation of PSA despite antiandrogen withdrawal;
• ECOG Performance Status < 2 with an expected survival of at least 6 months;
• Adequate renal function;
• Adequate hepatic function;
• Adequate hematologic status;
• No other prior malignancy is allowed except for the following: adequately-treated basal cell or squamous cell skin cancer, adequately treated Stage I or II bladder cancer from which the subject is currently in complete remission, or any other cancer from which the subject has been disease free for 5 years;
• Subjects must have recovered from all acute toxicities from prior treatment;
• Screening visit phenotyping procedures must have been completed successfully;
• No blood transfusion within the previous 2 weeks of signature of the informed consent;
• Expected cooperation of the subject for the treatment and follow up must be obtained and documented;
• Written informed consent must be obtained and documented.

Exclusion Criteria:

• Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
• Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
• Subjects who have been receiving bisphosphonates for less than three months prior to the first Amonafide administration;
• Known history of brain metastases;
• Subjects who are HIV positive;
• Subjects who are hepatitis B surface antigen positive or have previously documented hepatitis C infection;
• Subjects who received treatment with Growth Factors (i.e. G-CSF, GM-CSF) within 2 weeks of the signature of the informed consent form;
• Subjects who had any major surgery within four weeks of first administration of Amonafide;
• Subjects with a history of a psychological illness or condition which may interfere with the subjects ability to understand or comply with the requirements of the study;
• Subjects who received an investigational new drug within 30 days of the first dose of Amonafide;
• Any other known condition, which in the investigator’s opinion would not make the subject a good candidate for the trial.

California
      USC Norris Comprehensive Cancer Center, Los Angeles,  California,  90033,  United States; Recruiting
Maryland
      Cancer Center at John Hopkins, Baltimore,  Maryland,  21231,  United States; Not yet recruiting
Missouri
      Barnard Cancer Center, St. Louis,  Missouri,  63110,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States; Recruiting
New York
      Herbert Irving Cancer Center, New York,  New York,  10032-3789,  United States; Recruiting
Ohio
      The Cleveland Clinic, Cleveland,  Ohio,  44195,  United States; Recruiting
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
Washington
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109,  United States; Recruiting

Study ID Numbers:  0001A2-200-US
Record last reviewed:  October 2004
Record first received:  July 14, 2004
ClinicalTrials.gov Identifier:  NCT00087854
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10