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ZD 1839 in Treating Patients With Recurrent Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on ZD 1839 in Treating Patients With Recurrent Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ZD 1839 in Treating Patients With Recurrent Prostate Cancer Clinical research trials and ZD 1839 in Treating Patients With Recurrent Prostate Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including ZD 1839 in Treating Patients With Recurrent Prostate Cancer. ZD 1839 in Treating Patients With Recurrent Prostate Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a ZD 1839 in Treating Patients With Recurrent Prostate Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their ZD 1839 in Treating Patients With Recurrent Prostate Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Recurrent Prostate Cancer  ZD 1839 in Treating Patients With Recurrent Prostate Cancer
ZD 1839 in Treating Patients With Recurrent Prostate Cancer
For Condition: recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent prostate cancer.
Details: OBJECTIVES: I. Determine the percentage of patients with recurrent prostate cancer experiencing at least a 50% decline in prostate-specific antigen (PSA) after receiving ZD 1839. II. Determine the duration of PSA decline in patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the quality of life of patients treated with this drug. V. Determine the time to progression in patients treated with this drug. VI. Correlate epidermal growth factor receptor expression with PSA decline and time to progression in patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 twice daily on day 1 and once daily on days 2-28 of the first course and then once daily on days 1-28 of subsequent courses. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. At the discretion of the pharmaceutical company, patients who show evidence of prostate-specific antigen response may continue on ZD 1839 as long as they demonstrate benefit from this treatment extension. Quality of life is assessed at baseline, before each study course, at completion of study, and then annually during the treatment extension (if applicable). Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent prostate cancer - No metastatic disease (pelvic lymph nodes are considered metastatic disease) - Surgically castrated OR Medically castrated (testosterone less than 50 ng/mL); Must continue luteinizing hormone-releasing hormone (LHRH) analog therapy - Biochemical progression, defined by at least 2 consecutive rising PSA levels (at least 1 week apart) over a prior reference value - PSA at least 5 ng/mL --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy except epoetin alfa - Chemotherapy: No prior chemotherapy for recurrent prostate cancer; No concurrent suramin - Endocrine therapy: See Disease Characteristics; At least 8 weeks since prior bicalutamide or nilutamide; At least 4 weeks since prior flutamide; At least 4 weeks since prior megestrol or corticosteroids; No prior estramustine for recurrent prostate cancer; No concurrent anticancer hormonal therapy except LHRH analog therapy for medically castrated patients - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: See Disease Characteristics; Recovered from prior oncologic or other major surgery; No surgery during or for 1 week after study - Other: Recovered from prior anticancer therapy; At least 4 weeks since prior ketoconazole, PC-SPES, or saw palmetto; No concurrent systemic retinoids; No other concurrent anticancer therapy or investigational agents (e.g., coenzyme Q-10, PC-SPES, or saw palmetto); Concurrent intravenous bisphosphonates allowed if initiated before study --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-1 - Life expectancy: At least 6 months - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 75,000/mm3 - Hepatic: No concurrent unstable or uncompensated hepatic disease; Bilirubin no greater than 1.25 times upper limit of normal (ULN); ALT or AST no greater than 2.5 times ULN - Renal: No concurrent unstable or uncompensated renal disease; Creatinine no greater than 2 times ULN - Cardiovascular: No concurrent unstable or uncompensated cardiac disease - Pulmonary: No concurrent unstable or uncompensated respiratory disease - Other: Fertile patients must use effective contraception; No concurrent ocular inflammation or infection; No new neurologic symptoms or signs consistent with acute or evolving spinal cord compression confirmed by MRI; No other severe or uncontrolled systemic disease; No other significant clinical disorder or laboratory finding that would preclude study; No blood donation during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Study Chair, Jonsson Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000069302; NCI-G02-2059,UCLA-010402201,ZENECA-1839US/0040
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033579
Other Recurrent Prostate Cancer Studies:
1. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
2. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
3. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
4. Hormone Therapy in Treating Men With Stage IV Prostate Cancer
5. BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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ZD 1839 in Treating Patients With Recurrent Prostate Cancer
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