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BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer Clinical research trials and BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer clinical trial. Human subjects often get the best healthcare available for their BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer  BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as BMS-247550 and estramustine, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether BMS-247550 is more effective with or without estramustine in treating prostate cancer. PURPOSE: Randomized phase I/II trial to study the effectiveness of BMS-247550 with or without estramustine in treating patients who have progressive prostate cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BMS-247550 combined with estramustine in patients with progressive androgen-independent adenocarcinoma of the prostate. (Phase I) - Compare the safety and efficacy of BMS-247550 with or without estramustine in this patient population. (Phase II) - Correlate the clinical outcomes with reverse transcriptase-polymerase chain reaction-based assay for prostate-specific antigen mRNA in patients treated with these regimens. OUTLINE: This is a dose-escalation study of BMS-247550 (phase I) followed by a randomized, multicenter study (phase II). - Patients receive BMS-247550 IV over 3 hours on day 2 and oral estramustine 3 times daily on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive BMS-247550 IV over 3 hours at the MTD on day 2 and estramustine as in phase I. - Arm II: Patients receive BMS-247550 IV over 3 hours at the MTD on day 1. Treatment in both arms repeats as in phase I. Patients are followed every 12 weeks until disease progression. PROJECTED ACCRUAL: A total of 3-12 patients will be accrued for phase I of this study and a total of 44-92 patients (22-46 per treatment arm) will be accrued for phase II of this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Must have disease progression meeting 1 of the following criteria: - Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart - Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI - New metastatic lesions by radionuclide bone scan - The most recent PSA must be at least 4 ng/mL if no measurable disease is present - Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms - Serum testosterone no greater than 50 ng/mL - One of the following therapies for maintenance of castrate status required: - Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone - Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy - Prior surgical orchiectomy - Developed disease progression after discontinuation of megestrol - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of bleeding disorder that would preclude anticoagulation with warfarin Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) - PT/PTT normal (unless anticoagulated for other reasons [e.g., atrial fibrillation]) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No significant cardiovascular disease - No symptomatic congestive heart failure - No New York Heart Association class III or IV heart disease - No active unstable angina pectoris - No cardiac arrhythmia - No myocardial infarction within the past 6 months - No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months Pulmonary: - No pulmonary embolism within the past 6 months Other: - Fertile patients must use effective contraception - No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones - No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin - No other concurrent active malignancy except nonmelanomatous skin cancer - Disease not considered currently active if completely treated with less than a 30% risk for relapse - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever - No concurrent immunotherapy Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - No prior palliative radiotherapy to more than 25% of bone marrow - No prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - No concurrent therapeutic radiotherapy - Concurrent focal radiotherapy for palliation of bone disease-related symptoms allowed at the investigator's discretion Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery Other: - No other concurrent anticancer investigational or commercial agents or therapies - No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, or St. John's Wort) - No concurrent combination antiretroviral therapy for HIV-positive patients - No initiation of bisphosphonates immediately before or during study - Concurrent bisphosphonates allowed if developed disease progression while on stable doses - Concurrent daily multivitamin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamKelly, Study Chair, Memorial Sloan-Kettering Cancer Center
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068935; NCI-3634,MSKCC-01064,MSKCC-01064A
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025194
Other Adenocarcinoma Of The Prostate Studies:
1. Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
2. Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
3. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
4. BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
5. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
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