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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 Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
2. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
3. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
4. Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
5. Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
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Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
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