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Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate Clinical research trials and Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate. Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate clinical trial. Human subjects frequently get the finest healthcare available for their Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate  Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate
Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate
For Condition: Prostate Cancer
Status: Terminated
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Phase I: The goal of this clinical research study is to find the highest dose of estramustine phosphate administered intravenously in combination with a fixed dose of Taxol (paclitaxel) that can be given safely to participants with prostate cancer who have failed to further benefit from hormone treatment. Phase II: The goal of this clinical research study is to find out if the combination of the drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has not responded to hormone treatment. A second goal is to find out if the side effects of these drugs can be reversed. The safety of these drugs will also be studied.
Details: To determine the maximum tolerated dose of intravenous estramustine phosphate combined with Taxol. To estimate the complete and partial response rates to treatments with intravenous estramustine phosphate combined with Taxol in the treatment of hormone-refractory adenocarcinoma of the prostate. To determine the qualitative and quantitative toxicity of the combination of intravenous estramustine phosphate and Taxol.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: Inclusion: - Patients with histologic proof of adenocarcinoma of the prostate and must have failed conventional hormonal therapy. - Patients must have osteoblastic bone metastases. At least one osteoblastic lesion must be documented by plain film. Patients with mixed or osteolytic bone metastases must have a biopsy to exclude histologic variants of prostate cancer or metastasis from another primary (for phase II only). - Patients must have evidence of progression of disease as demonstrated by 2 consecutive rise in PSA (an absolute change of at least 1 ng/mL) over 4 weeks. - Patients on flutamide, nilutamide, or bicalutamide should be discontinued from flutamide or nilutamide and bicalutamide for at least 4 weeks and 8 weeks, respectively. - Patients must have an expected survival of at least three months and a Zubrod performance status of < 2 (Zubrod scale; Appendix B). - Patients may receive no concurrent chemotherapy or immunotherapy. - Patients must have castrate serum testosterone levels (< 30 ng/dl). For patients who are medically castrated, lutenizing 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; adequate hepatic function defined with a bilirubin of < 1.5 mg% and SGOT (AST) < 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated). - Patients must be >= 18 years old. - Patients may have received oral EMP or no more than one cytotoxic therapy. - Patients must sign a written informed consent form prior to treatment. Exclusion: - Patients with severe intercurrent infection. - Patients with prior exposure to Taxol. - Patients whose tumors contain small cell or sarcomatoid elements. - Patients with evidence of conduction block or active myocardial ischemia on ECG. - Patients with a history of prior malignancy (except noninvasive cutaneous carcinoma). - Patients with a history of thromboembolism.
Total Enrollment: 58
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: DM98-268;
Study Start Date: June 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038168
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2. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
3. Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis
4. "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
5. Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate
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Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate
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