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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00006002
First received: July 5, 2000
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: dexamethasone
Drug: semaxanib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of SU5416 (NSC# 686819) in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2000
Study Completion Date: January 2006
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006002

Locations
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
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
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
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00006002     History of Changes
Other Study ID Numbers: 10428, UCCRC-10428, UCCRC-NCI-49, NCI-49
Study First Received: July 5, 2000
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Semaxinib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014