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A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer

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

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.

Inclusion 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

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)

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Carolyn Paradise, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cell Therapeutics


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



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