Clinical trial NCT00004026: CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy
Official title: A Phase II Study of CT-2584 Mesylate in Patients With Hormone Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: New Orleans
country: United States
facility: Stanley Scott Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: CTI BioPharma
name: Carolyn Paradise, MD
role: STUDY_CHAIR
References: