SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
NCT ID: NCT00006002
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2000-06-30
2006-01-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
dexamethasone
semaxanib
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
semaxanib
Interventions
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dexamethasone
semaxanib
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Walter M. Stadler, MD, FACP
Role: STUDY_CHAIR
University of Chicago
Locations
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
City of Hope Medical Group
Pasadena, California, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
LaGrange Memorial Hospital
LaGrange, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Division of Hematology/Oncology
Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Countries
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Other Identifiers
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UCCRC-10428
Identifier Type: -
Identifier Source: secondary_id
UCCRC-NCI-49
Identifier Type: -
Identifier Source: secondary_id
NCI-49
Identifier Type: -
Identifier Source: secondary_id
10428
Identifier Type: -
Identifier Source: org_study_id