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Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma Clinical research trials and Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma. Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma clinical trial. Subjects typically recieve the finest healthcare available for their Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma  Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
For Condition: Prostate Cancer
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The three study drugs (Thalidomide, Taxol, and Estramustine) used in this study are all chemotherapy drugs used in shrinking the cancer.
Details: 1. Evaluate the maximum tolerated dose of oral daily thalidomide along with Paclitaxel (100 mg/m2 as a 3-hour infusion weekly x 2, q 21 days) and oral estramustine phosphate (140 mg p.o. t.i.d. 5 days per week x 2 weeks, q 21 days) for patients with metastatic androgen-independent prostate carcinoma. 2. Evaluate the efficacy of this regimen for patients with metastatic Androgen-Independent Prostate Cancer who failed up to two prior non-paclitaxel containing chemotherapy regimens, as measured by: 2A. The objective response rate and ?PSA response rate? of the combination treatment in patients with AI-PCa progressing after chemotherapy. 2B. Secondary endpoints: calculate time to disease progression, effect on performance status, analgesic consumption, and survival. 3. To evaluate the toxicity of the combination treatment in patients with metastatic AI-PCa progressing after chemotherapy.
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: - Signed informed consent. - Histologic demonstration of adenocarcinoma of the prostate. Patients with variant histologies (ductal carcinoma, small cell carcinoma) are eligible only for the Phase I part of the trial, but are excluded from the Phase II. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA. Some pathologic material must be available for review. Indicator need not be biopsy proven if the clinical presentation is characteristic. - Androgen-Independent progression of prostate carcinoma, as shown by: a) Serum testosterone level of < 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone (LHRH agonists) should continue, and b) Either symptomatic progression, or, if patient is asymptomatic, then a rising serum PSA in two occasions at least 1 week apart, with a minimum pre-treatment serum PSA of 5. - Patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal). - Patients with nodal and/or visceral disease are eligible. - Patients may have up to 2 prior chemotherapy regimens for prostate cancer, provided that more than 3 weeks have elapsed since the last treatment and patients have recovered from toxicity. Ketoconazole is considered chemotherapy. Prior Taxanes are allowed in both the Phase I and Phase II part of the trial. For the Phase II part of the study, patients must have progressed after >/= 1 and 18 years old. d) No clinical history of heart disease and a normal ECG, OR an ejection fraction of at least 45% (by ECHO, MUGA or ventriculography). e) SGOT/SGPT and conjugated bilirubin less than twice the upper limit of normal. f) Serum creatinine < 2.0 mg/dl (or, if creatinine > 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula: CLcr= [(140-age) x wt (kg)] / [72 x serum creatinine (mg/dl)]. g) ANC>1500/mm3; Platelets >100,000/mm3; hemoglobin > 9.0 gm/dl. Exclusion: - Patients with variant histologies (ductal or small cell carcinoma) are excluded from the phase II part of the trial (are eligible for the phase I part). - Patients with no prior chemotherapy for prostate cancer are excluded from the phase II part of the study. - Patients with CNS metastases or serious medical illnesses, active or uncontrolled infections, significant psychiatric disorders that preclude giving informed consent, patients with NCI grade > 2 peripheral neuropathy or patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry are excluded from the trial.
Total Enrollment: 57
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID00-087;
Study Start Date: October 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038246
Other Prostate Cancer Studies:
1. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
2. Treatment With an Investigational Compound for the Prevention of Prostate Cancer
3. GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
4. The Effect of Zometa on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
5. An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients
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Study of Paclitaxel, Estramustine Phosphate and Thalidomide for Patients With Metastatic Androgen-Independent Prostate Carcinoma
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