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Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer Clinical research trials and Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer. Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer  Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer
Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer
For Condition: Prostate Cancer
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.
Details: OBJECTIVES: 1. To define the maximum tolerated dose of weekly docetaxel in combination with fixed-dose oral STI571 in adult men with metastatic androgen-independent prostate cancer (AIPC). 2. To determine the qualitative and quantitative toxicity of the combination of oral STI571 and docetaxel. 3. Evaluate PSA modulation with STI571 alone at thirty days in patients with AIPC. 4. Obtain a preliminary estimate of the response rate in AIPC to the combination of STI571 and docetaxel. 5. Obtain tissue for correlative science studies (these are optional studies).
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Safety Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: Inclusion: - Patients with histologic proof of adenocarcinoma of the prostate and must have progressed on conventional hormonal therapy. - Patients must have bone metastases which can be demonstrated by bone scans. Lytic bone lesions should be considered for biopsy if there is a clinical suspicion of histologic conversion to small cell carcinoma. - Patients must have evidence of progression of disease. PSA- progression is defined as 2 consecutive increments in PSA (an absolute change of at least 1ng/mL) over 4 weeks. An increase by 25% of the product of bidimensional disease qualifies as progression. An increase in the number of metastatic lesions on bone scan qualifies as progression. - All patients must have a minimum PSA of 1ng/ml. - Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 8 weeks. If progression is documented as below prior to this time interval, patients are eligible. - Patients must have a performance status of < 2 (ECOG). - Patients must have an expected survival from cancer or co-morbidity of at least three months. - Patients may receive no concurrent chemotherapy, immunotherapy or ketoconazole. - Patients should not have received prior chemotherapy or radiation within the last 30 days and no Strontium or Samarium within the last 90 days. - Patients must have castrate serum testosterone levels (< 30ng/dl). For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression. - Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm3 and platelet count of > 100,000/mm3. - Patients should have adequate hepatic function defined with a bilirubin of < 1.5 mg/dl and AST/ALT < 2X the upper limits of normal. - Patients should have adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine < 1.5 X upper limit of normal. - Fully recovered from any previous surgery (at least 4 weeks since major surgery. - Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. The only approved consent is attached to this protocol. Exclusion: - Patients with severe intercurrent infection. - Patients whose tumors contain small cell or sarcomatoid elements. - Patients with NYHA Class III/IV CHF, unstable angina or MI in the last 6 months or evidence of active myocardial ischemia on ECG. - CNS metastases that are uncontrolled. - Prior hypersensitivity or dose-limiting toxicity with docetaxel. - Oxygen-dependent lung disease - Contraindications to corticosteroids. - Uncontrolled severe hypertension or uncontrolled diabetes mellitus. - Second malignancies (except non-melanoma skin cancer) unless disease-free for 3 years. - Overt psychosis or mental disability or otherwise incompetent to give informed consent. - Patients with a history of non-compliance with medical regimens or who are considered potentially unreliable.
Total Enrollment: 48
Location and Contact Information:
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID01-271;
Study Start Date: October 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038194
Other Prostate Cancer Studies:
1. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
2. Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
3. Safety and Efficacy Study of Omnitarg (Pertuzumab) to Treat Castration-Resistant Prostate Cancer
4. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
5. To explore racial differences in potential risk factors for developing prostate cancer in the VA population.
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Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) with Escalating Doses of Docetaxel in Patients with Metastatic Androgen-Independent Prostate Cancer
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