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CP-724,714 in Treating Patients With Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about CP-724,714 in Treating Patients With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CP-724,714 in Treating Patients With Metastatic Breast Cancer Clinical research trials and CP-724,714 in Treating Patients With Metastatic Breast Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as CP-724,714 in Treating Patients With Metastatic Breast Cancer. CP-724,714 in Treating Patients With Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a CP-724,714 in Treating Patients With Metastatic Breast Cancer clinical trial. Participants frequently get the best healthcare available for their CP-724,714 in Treating Patients With Metastatic Breast Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CP-724,714 in Treating Patients With Metastatic Breast Cancer  CP-724,714 in Treating Patients With Metastatic Breast Cancer
CP-724,714 in Treating Patients With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,Male Breast Cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: CP-724,714 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of CP-724,714 in treating patients who have metastaticHER2-overexpressing breast cancer.
Details: OBJECTIVES: - Determine the safety and tolerability of CP-724,714 in patients with metastatic HER2-overexpressing breast cancer. - Determine the maximum tolerated dose of this drug in these patients. - Determine, preliminarily, any antitumor activity of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the relationship of drug-related adverse events to pharmacokinetic exposure parameters in these patients. - Determine the relationship of changes in serum HER2 extracellular domain and HER2 receptor tyrosine kinase phosphorylation to pharmacokinetic exposure parameters and clinical outcome in patients treated with this drug. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral CP-724,714 on days 1 and 3-21 during course 1 and then daily during subsequent courses. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CP-724,714 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 30 days. PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed HER2-overexpressing breast cancer - Prior or newly documented HER2 amplification by fluorescence in situ hybridization (FISH) - Progressive metastatic disease - Must have received at least one prior chemotherapy regimen for metastatic breast cancer - At least 1 measurable or evaluable lesion - At least 1 lesion accessible for 2 separate core biopsies for pharmacodynamic evaluation - No known or clinically suspected brain metastases or leptomeningeal disease - No symptomatic edema or third-space fluid (e.g., ascites or pleural effusions) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3* - Platelet count at least 100,000/mm^3* NOTE: *Without hematopoietic growth factors or transfusions Hepatic - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - No known hepatitis B or C infection Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - 12-lead ECG with normal tracing - No significant ECG changes that require medical intervention - QTc interval less than 460 msec - No history of torsade or other symptomatic QTc abnormality - LVEF greater than 50% by MUGA - No history of cardiovascular disease (i.e., ischemic heart disease, arrhythmia, or congestive heart failure) unless asymptomatic for the past year with no requirement for antiarrhythmics or a clinically significant medical management change Gastrointestinal - Able to take oral medication - No gastrointestinal abnormality that would require medications (including all antacids) - No persistent symptoms of an esophageal or digestive disorder Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV infection - No active infection - No concurrent uncontrolled systemic disorders or laboratory abnormalities that would preclude study drug safety evaluation - No mental disorder that would preclude study compliance or ability to give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy - At least 4 weeks since prior trastuzumab (Herceptin) - No more than 2 prior trastuzumab-based regimens for advanced disease - At least 4 weeks since other prior biologic therapy or immunotherapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - At least 6 months since prior doxorubicin or doxorubicin equivalents without any prior or developing signs or symptoms of cardiomyopathy - No cumulative doses of more than 300 mg/m^2 - No more than 1 prior anthracycline- or anthracenedione-containing regimen (except with approval of the sponsor) - No prior high-dose chemotherapy with hematopoietic stem cell transplantation - No concurrent anticancer chemotherapy Endocrine therapy - At least 2 weeks since prior hormonal therapy for the primary disease - Concurrent hormone replacement therapy or luteinizing hormone-releasing hormone agonists allowed - No concurrent anticancer hormonal therapy, including tamoxifen Radiotherapy - At least 4 weeks since prior radiotherapy - No prior radiotherapy to the only disease site that would be assessed for response - No concurrent radiotherapy Surgery - At least 3 weeks since prior major surgery (2 weeks for minor surgery) - No prior partial or complete gastrectomy Other - Recovered from prior therapy - At least 4 weeks since prior investigational treatment - No concurrent antiarrhythmics - No concurrent antacids - No concurrent anticoagulant at therapeutic doses - Coumarin or heparin derivatives allowed for the prevention of deep vein thrombosis or port patency - No other concurrent experimental anticancer medications for breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynBritten, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Carolyn Britten 310-825-8195
Additional Information:
Study ID Numbers: CDR0000271533; PFIZER-A4031001,UCLA-0209105
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055926
Other Male Breast Cancer Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
2. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
3. Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
4. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
5. Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Related Studies:
Other Male Breast Cancer Clinical Trials
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CP-724,714 in Treating Patients With Metastatic Breast Cancer
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