Prostate Cancer Clinical Trial
SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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.
Full 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 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
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There are 18 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Pasadena California, 91105, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60640, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
LaGrange Illinois, 60525, United States
Maywood Illinois, 60153, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61602, United States
Springfield Illinois, 62701, United States
Fort Wayne Indiana, 46885, United States
South Bend Indiana, 46617, United States
Saint Joseph Michigan, 49085, United States
Durham North Carolina, 27705, United States
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