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EPO906 Therapy in Patients with Prostate Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on EPO906 Therapy in Patients with Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. EPO906 Therapy in Patients with Prostate Cancer Clinical research trials and EPO906 Therapy in Patients with Prostate Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including EPO906 Therapy in Patients with Prostate Cancer. EPO906 Therapy in Patients with Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a EPO906 Therapy in Patients with Prostate Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their EPO906 Therapy in Patients with Prostate Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "E" Clinical Trials Conditions > EPO906 Therapy in Patients with Prostate Cancer  EPO906 Therapy in Patients with Prostate Cancer
EPO906 Therapy in Patients with Prostate Cancer
For Condition: Prostatic Neoplasms
Status: Suspended
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria The following patients may be eligible for this study: - Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible - Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy - Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents - Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks - For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver - For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period) - Must have a life expectancy of greater than three (3) months - Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal - For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease). Exclusion Criteria The following patients are not eligible for the study: - Patients with symptomatic CNS metastases or leptomeningeal involvement - Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 - Patients with severe cardiac insufficiency - Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports - Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed) - Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide) - Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease - Patients with disease measurable only by bone scan - Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis) - History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer - Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry - Patients with radiation therapy or chemotherapy within the last four weeks - Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae - HIV+ patients
Total Enrollment: 48
Location and Contact Information:
University of Maryland - Greenbaum Cancer Center
Baltimore, Maryland, 21201
United States
Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, 08901
United States
Pacific Shores Medical Group
Long Beach, California, 90813
United States
California Pacific Medical Center
San Francisco, California, 94115
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CEPO906A-2204;
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035113
Other Prostatic Neoplasms Studies:
1. EPO906 Therapy in Patients with Prostate Cancer
2. Study of a 6-Month Sustained-release Formulation of Leuprolide in Prostate Cancer
3. Ketoconazole Plus Docetaxel to Treat Prostate Cancer
4. A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
5. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
Related Studies:
Other Prostatic Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
EPO906 Therapy in Patients with Prostate Cancer
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