RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. CT-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor.

PURPOSE: Randomized phase II trial to study the effectiveness of CT-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer	Drug: CT-2584	Phase II

Further Study Details: 

OBJECTIVES: I. Compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of CT-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate.

PROTOCOL OUTLINE: This is a randomized, multicenter study.

Patients are randomized to 1 of 2 treatment arms:

Arm I: Patients receive CT-2584 IV over 6 hours daily for 3 days every 3 weeks.

Arm II: Patients receive CT-2584 IV over 6 hours once every 7 days for 3 weeks.

Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 80 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven metastatic adenocarcinoma of the prostate; Refractory to hormonal therapy; Failed at least 1 nonhormonal therapy (prior radiotherapy allowed, but does not constitute nonhormonal therapy)
• No CNS metastases

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior systemic biologic therapy for prostate cancer and recovered
• Chemotherapy: At least 4 weeks since prior chemotherapy (12 weeks for strontium-89 and 6 weeks for bicalutamide) and recovered
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: See Disease Characteristics; No concurrent radiotherapy
• Surgery: At least 3 weeks since prior major thoracic or abdominal surgery
• Other: At least 4 weeks since other prior investigational drugs (except bisphosphonates) and recovered

--Patient Characteristics--

• Age: 18 and over
• Performance status: 60-100%
• Life expectancy: Not specified
• Hematopoietic: No known or suspected red blood cell disorder (e.g., hereditary spherocytosis, paroxysmal nocturnal hematuria, sickle cell trait, autoimmune hemolytic disorder)
• Hepatic: Bilirubin no greater than 1.5 mg/dL; No severe liver dysfunction, particularly, no impaired hepatic synthetic functions as evidenced by prolonged prothrombin time or otherwise unexplained serum albumin less than 3 g/dL
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: No evidence of congestive heart failure; No clinically significant cardiac arrhythmia; No prior or concurrent symptoms of acute coronary artery disease; No significant cardiac valve disease (e.g., aortic stenosis, valve prosthesis)
• Pulmonary: No prior asthma during adulthood that required therapy
• Other: No prior seizures or drug related anaphylactic reactions; No history of microangiopathy (e.g., cavenous hemangioma, prior thrombotic thrombocytopenic purpura)

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
Louisiana
      Stanley Scott Cancer Center, New Orleans,  Louisiana,  70112,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States
      Our Lady of Mercy Medical Center, Bronx,  New York,  10466,  United States
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Study chairs or principal investigators

Carolyn Paradise,  Study Chair,  Cell Therapeutics   

Study ID Numbers:  CDR0000067257; CTI-1038; CPMC-IRB-8781
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00004026
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08