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Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer Clinical research trials and Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer. Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer  Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
For Condition: stage 4 prostate cancer,recurrent prostate cancer,stage 3 prostate cancer,Thromboembolism
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Anticoagulant drugs such as warfarin may reduce the risk of blood clots. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus warfarin in treating patients who have prostate cancer.
Details: OBJECTIVES: I. Determine the safety, efficacy, and durability of docetaxel and estramustine followed by doxorubicin and ketoconazole in patients with high-risk, androgen-independent prostate cancer. II. Determine whether anticoagulation with warfarin can reduce the frequency of thromboembolic complications associated with estramustine in these patients. PROTOCOL OUTLINE: Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 3 weekly. Patients also receive oral warfarin daily. Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Regimen B: After completion of regimen A, patients receive doxorubicin IV over 30 minutes weekly and oral ketoconazole twice daily. Treatment repeats every 4 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly until disease progression. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed prostate cancer - High risk as defined by any 2 of the following: Karnofsky performance status of 70-80%; Lactate dehydrogenase greater than 200 U/mL; Hemoglobin less than 13 g/dL - Prostate-specific antigen (PSA) at least 4 ng/mL - Progressive disease based on any 1 of the following: Rise in PSA level of at least 25% above baseline; At least 3 determinations taken at weekly intervals OR At least 2 determinations taken at monthly intervals; New or progressive soft tissue masses on MRI or CT scan; Radionucleotide bone scan with new metastatic lesion(s) - Serum testosterone no greater than 30 ng/mL - If no prior surgical orchiectomy, castrate levels of serum testosterone must be maintained with continuation of gonadotropin releasing hormone analogs - If receiving an anti-androgen, must show progression of disease after stopping anti-androgen therapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 1 prior chemotherapy regimen - Endocrine therapy: See Disease Characteristics - Radiotherapy: No more than 1 prior course of palliative radiotherapy; No more than 1 prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: See Disease Characteristics; Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; SGOT/SGPT no greater than 1.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No significant cardiovascular disease; No New York Heart Association class III or IV heart disease; No active angina pectoris; No myocardial infarction within the last 6 months; Ejection fraction at least 45% by echocardiogram or MUGA; No prior hemorrhagic or thrombotic cerebral vascular accident; No deep venous thrombosis - Pulmonary: No pulmonary embolism within the past 6 months - Other: No history of bleeding disorder or gastrointestinal bleeding that would preclude anticoagulation with warfarin; No other concurrent malignancy except non-melanoma skin cancer or any curatively treated malignancy considered to be at less than 30% risk of relapse; No severe infection; No severe malnutrition; No other serious medical illness that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamKelly, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068536; NCI-G01-1927,MSKCC-00113
Study Start Date: September 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014352
Other Stage 3 Prostate CancerStudies:
1. Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
2. Warfarin in Preventing Blood Clots in Cancer Patients With Central Venous Catheters
3. Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
4. Prevention of Recurrent Venous Thromboembolism (PREVENT)
5. Epidemiology of Venous Thromboembolism
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other New York Clinical Trials
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Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
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