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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006002
Recruitment Status : Completed
First Posted : August 29, 2003
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: dexamethasone Drug: semaxanib Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer
Study Start Date : June 2000
Actual Primary Completion Date : September 2002
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm B
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.
Drug: dexamethasone
Drug: semaxanib
Experimental: Arm A
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
Drug: semaxanib

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • 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


  • No pulmonary embolism within the past 3 months


  • 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


Biologic therapy:

  • Not specified


  • No prior systemic chemotherapy
  • No other concurrent chemotherapy
  • No other concurrent investigational antineoplastic drugs

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006002

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
City of Hope Medical Group
Pasadena, California, United States, 91105
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Division of Hematology/Oncology
Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
United States, North Carolina
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago

Responsible Party: University of Chicago Identifier: NCT00006002     History of Changes
Other Study ID Numbers: 10428
First Posted: August 29, 2003    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors