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CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CT-2584
chemotherapy
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • UCSF Cancer Center and Cancer Research Institute
  • Stanley Scott Cancer Center
  • Johns Hopkins Oncology Center
  • Our Lady of Mercy Medical Center
  • Herbert Irving Comprehensive Cancer Center
  • University of Washington Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 14, 2020
Sponsor
CTI BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT00004026
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
December 1998 (Actual)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CTI BioPharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CT-2584
Intervention Type
Drug
Intervention Name(s)
chemotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Paradise, MD
Organizational Affiliation
CTI BioPharma
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
Stanley Scott Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Our Lady of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States

12. IPD Sharing Statement

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CT-2584 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Therapy

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