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ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy. ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Test subjects typically receive the most expert healthcare available for their ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy  ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more effective in treating prostate cancer that has not responded to hormone therapy. PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients who have prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Compare the efficacy of 2 different doses of ZD 1839, in terms of objective response, PSA response, and duration of response, in patients with hormone-refractory adenocarcinoma of the prostate. II. Compare the tolerability and quantitative toxicity of these regimens in these patients. III. Determine whether there is an association between any response or stable disease and clinical benefit as assessed by changes in quality of life of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral, low-dose ZD 1839 twice daily on day 1 and once daily on days 2-28 during course 1 and then once daily on days 1-28 during subsequent courses. Arm II: Patients receive oral, high-dose ZD 1839 as in arm I. Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of each course during study, and then at 4 weeks after study. Patients with stable or responding disease are followed at 4 weeks and then every 3 months until disease progression. All other patients are followed at 4 weeks only. PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed adenocarcinoma of the prostate - PSA at least 20 ng/mL at study entry - Must have documented evidence of disease progression, defined by 1 of the following conditions: Rising PSA documented after discontinuation of peripheral antiandrogens; Minimum evidence of progression is a 25% increase in PSA over the reference value, provided that the increase is at least 5 ng/mL; Must have a first increase in PSA documented at least 1 week after the reference value and a second increase in PSA documented at least 1 week after the first increase; Progressive measurable disease during androgen ablative therapy (including medical or surgical castration) - Castrate level (no greater than 50 ng/mL) of testosterone required if receiving medical androgen-ablative therapy at study entry - Concurrent luteinizing hormone-releasing hormone agonist therapy required if receiving this medication at study entry --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent epoetin alfa allowed - Chemotherapy: No prior chemotherapy; No concurrent cytotoxic therapy - Endocrine therapy: See Disease Characteristics; At least 4 weeks since prior peripheral antiandrogens (6 weeks for bicalutamide); Concurrent steroids allowed if on stable dose for at least 4 weeks before study and no dose increase planned - Radiotherapy: At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy approved by the National Cancer Institute of Canada, Clinical Trials Group - Surgery: See Disease Characteristics; No concurrent ophthalmic surgery - Other: No prior investigational agents; No other concurrent investigational therapy; No concurrent ketoconazole; No concurrent high-dose narcotic therapy for pain (e.g., morphine equivalent dose more than 60 mg/day); Concurrent bisphosphonates allowed --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST/ALT no greater than 2.5 times ULN (5 times ULN if documented liver metastases) - Renal: Creatinine no greater than 2 times ULN - Other: No other malignancy within the past 5 years; No active uncontrolled bacterial, fungal, or viral infection; No significant neurological disorder that would preclude informed consent; No other serious illness or medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MalcolmMoore, Study Chair, National Cancer Institute of Canada
Ontario Cancer Institute
Toronto, Ontario, M4X 1K9
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Additional Information:
Study ID Numbers: CDR0000068915; CAN-NCIC-IND140
Study Start Date: April 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025116
Other Recurrent Prostate Cancer Studies:
1. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
2. Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
3. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
4. Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases
5. Vaccine Therapy in Treating Patients With Advanced Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Alberta Clinical Trials
Other Calgary Clinical Trials
ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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