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SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Clinical research trials and SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer. SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer  SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
For Condition: stage 3 prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, bicalutamide, leuprolide, or goserelin may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining SU5416, hormone therapy, and radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 plus hormone therapy and radiation therapy in treating patients who have prostate cancer.
Details: OBJECTIVES: I. Determine the safety of SU5416 in combination with standard androgen ablation and radiotherapy in patients with intermediate or advanced-stage prostate cancer. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of SU5416. Patients receive oral bicalutamide once daily or oral flutamide three times daily for at least 1 month followed by leuprolide or goserelin subcutaneously once monthly for four months. Beginning after the fourth administration of leuprolide or goserelin, patients receive radiotherapy 5 days a week for 7-8 weeks. Beginning one month before radiotherapy and continuing until 1 month after radiotherapy, patients receive SU5416 IV over 60 minutes on days 1 and 4. Treatment repeats weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-12 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3 of 12 patients experience dose-limiting toxicity. Patients are followed every 4-6 weeks for 4 months and then every 8-12 weeks for 8 months. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the prostate with at least 1 of the following: Clinical stage T2b or greater; Gleason score at least 8; Pretreatment PSA greater than 15 ng/mL; Pelvic and/or periaortic node(s) positive on abdominal/pelvic CT scan; Metastatic disease requiring palliation for local symptoms - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No concurrent anticancer chemotherapy - Endocrine therapy: Prior hormonal therapy of any duration allowed - Radiotherapy: No prior pelvic radiotherapy - Surgery: No prior prostatectomy - Other: No prior non-hormonal systemic therapy for prostate cancer; No other concurrent investigational or commercial agents or therapies for malignancy; No concurrent combination antiretroviral therapy for HIV --Patient Characteristics-- - Age: Not specified - Performance status: ECOG 0-2; Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); AST no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: No symptomatic congestive heart failure; No cardiac arrhythmia; No uncompensated coronary artery disease on ECG or physical exam; No myocardial infarction or severe unstable angina within the past 6 months; No deep venous or arterial thrombosis within the past 3 months - Pulmonary: No pulmonary embolism within the past 3 months - Other: No other concurrent uncontrolled illness; No ongoing or active infection; No diabetes mellitus with severe peripheral vascular disease; No psychiatric illness or social condition that would preclude study; No prior allergic reactions attributed to compounds of similar chemical or biological composition to SU5416 or Cremophor EL vehicle; No prior severe allergic reactions to paclitaxel or docetaxel
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterStadler, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
United States
Radiation Oncology
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: CDR0000069024; NCI-4390,UCCRC-NCI-4390
Study Start Date: November 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026377
Other Stage 3 Prostate Cancer Studies:
1. Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
2. Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
3. Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
4. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
5. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other Illinois Clinical Trials
Other LaGrange Clinical Trials
SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
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