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Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Clinical research trials and Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer  Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
For Condition: stage 3B breast cancer,stage 3C breast cancer,recurrent breast cancer,Male Breast Cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining lonafarnib and trastuzumab with paclitaxel in treating patients who have HER2-overexpressingstage IIIB, stage IIIC, or stage IV breast cancer.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of lonafarnib in combination with trastuzumab (Herceptin®) and paclitaxel in patients with HER2/neu-overexpressing stage IIIB, IIIC, or IV breast cancer. - Determine the qualitative and quantitative toxicity of this regimen in these patients. Secondary - Determine the pharmacokinetic profiles of these drugs in these patients. - Corrrelate the pharmacodynamics with the pharmacokinetics of this regimen in these patients. - Correlate the pharmacokinetics and pharmacodynamics of this regimen with observed toxicity in these patients. - Determine the response to this regimen in patients with measurable disease. OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of lonafarnib. - Course 1: Patients receive a loading dose of trastuzumab (Herceptin®) IV over 90 minutes on day 1 and over 30 minutes on days 8 and 15. Patients also receive paclitaxel IV over 3 hours on day 1. - Course 2: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 and paclitaxel IV over 3 hours on day 2. Patients also receive oral lonafarnib twice daily on days 3-21. - Course 3 and all subsequent courses: Patients receive oral lonafarnib twice daily on days 1-21; trastuzumab IV over 30 minutes on days 1, 8, and 15; and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of lonafarnib 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 every 8 weeks until disease progression. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Stage IIIB, IIIC, or IV - HER2/neu overexpression - 3+ by immunohistochemistry - 2+ allowed if positive fluorescent in situ hybridization - Disease meets the following treatment criteria: - Paclitaxel/trastuzumab (Herceptin®) may be appropriate therapy - Anthracycline therapy is not a suitable approach - No clinical signs of CNS involvement - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-2 OR - WHO 0-2 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL (6.2 mmol/L) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases are present) - AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine clearance at least 40 mL/min Cardiovascular - Cardiac ejection fraction normal by MUGA - QTc interval no greater than 440 msec - No cardiac dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 3 months after study participation - No concurrent severe/unstable systemic disease - No infection - No circumstances that would preclude study participation (e.g., alcoholism or substance abuse) - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - More than 1 year since prior trastuzumab - No concurrent prophylactic growth factors Chemotherapy - More than 1 year since prior paclitaxel - More than 4 weeks since other prior chemotherapy Endocrine therapy - More than 1 day since prior hormonal therapy - More than 2 days since prior high-dose chronic steroids - More than 2 days since prior ethinyl estradiol - No concurrent high-dose chronic steroids - No concurrent ethinyl estradiol Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - Not specified Other - More than 2 days since prior administration of and no concurrent CYP3A4 inducers or inhibitors, including any of the following: - Gestodene - Itraconazole - Ketoconazole - Cimetidine - Erythromycin - Carbamazepine - Phenobarbital - Phenytoin - Rifampin - Sulfinpyrazone - No concurrent grapefruit juice - No other concurrent anticancer agents - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JanSchellens, , Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Institut Curie - Section Medicale *Recruiting*
Paris, , 75248
France
Recruiting Contact Person 33-1-4432-4100
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam, , 1066 CX
Netherlands
Recruiting Contact Person 31-20-512-2665
Additional Information:
Study ID Numbers: CDR0000327986; EORTC-16023,SPRI-P01900
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068757
Other Stage 4 Breast Cancer Studies:
1. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
2. Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
3. Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
4. Chemotherapy With or Without Monoclonal Antibody in Treating Women With Metastatic Breast Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
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Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
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