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SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
semaxanib
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy Progressive disease defined by 1 of the following criteria: New bone scan lesions New or progressive radiologic lesions Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following: Continued treatment with an LHRH agonist or prior orchiectomy Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide) Trial of antiandrogen withdrawal at least 4 weeks prior to study CNS metastasis allowed if: Previously treated Neurologically stable Oral or intravenous steroids or anticonvulsants not required Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease No history of myocardial infarction or severe unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant Fertile patients must use effective contraception No significant uncontrolled underlying medical or psychiatric illness No serious active infection No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy No other concurrent investigational antineoplastic drugs Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery

Sites / Locations

  • Cancer Center and Beckman Research Institute, City of Hope
  • USC/Norris Comprehensive Cancer Center and Hospital
  • City of Hope Medical Group
  • University of Illinois at Chicago
  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Cancer Care Specialists of Central Illinois, S.C.
  • Evanston Northwestern Health Care
  • Ingalls Memorial Hospital
  • LaGrange Memorial Hospital
  • Loyola University Medical Center
  • Division of Hematology/Oncology
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology, Inc.
  • Michiana Hematology/Oncology P.C.
  • Oncology Care Associates, P.L.L.C.
  • Veterans Affairs Medical Center - Durham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm B

Arm A

Arm Description

dexamethasone followed by SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment if tumor grows.

SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006002
Brief Title
SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet known whether SU5416 or dexamethasone is more effective in treating progressive prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of dexamethasone in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: Compare the time to progression in patients with hormone refractory prostate cancer treated with dexamethasone with or without SU5416. Determine the differences in PSA kinetics and PSA hazard score between these two regimens in this patient population. Determine the objective response rate and time to development of new lesions in these patients treated with SU5416. Determine the toxicity of SU5416 in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dexamethasone once a day 6 days a week. Treatment continues until disease progression, at which time patients cross over to arm II. Arm II: Patients receive oral dexamethasone as in arm I followed by SU5416 IV over 60 minutes twice weekly for 4 weeks. A smaller dose of dexamethasone is administered the day after SU5416. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 16 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm B
Arm Type
Experimental
Arm Description
dexamethasone followed by SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment if tumor grows.
Arm Title
Arm A
Arm Type
Experimental
Arm Description
SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
semaxanib
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy Progressive disease defined by 1 of the following criteria: New bone scan lesions New or progressive radiologic lesions Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following: Continued treatment with an LHRH agonist or prior orchiectomy Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide) Trial of antiandrogen withdrawal at least 4 weeks prior to study CNS metastasis allowed if: Previously treated Neurologically stable Oral or intravenous steroids or anticonvulsants not required Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease No history of myocardial infarction or severe unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant Fertile patients must use effective contraception No significant uncontrolled underlying medical or psychiatric illness No serious active infection No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy No other concurrent investigational antineoplastic drugs Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter M. Stadler, MD, FACP
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
City of Hope Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois, S.C.
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
LaGrange Memorial Hospital
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Division of Hematology/Oncology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
Michiana Hematology/Oncology P.C.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Oncology Care Associates, P.L.L.C.
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

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