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Capecitabine, Paclitaxel, and Trastuzumab 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 Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer Clinical research trials and Capecitabine, Paclitaxel, and Trastuzumab 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 Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer. Capecitabine, Paclitaxel, and Trastuzumab 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 Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer clinical trial. Participants frequently get the best healthcare available for their Capecitabine, Paclitaxel, and Trastuzumab 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 > Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer  Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , UNC Lineberger Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when administered in combination with paclitaxel and trastuzumab (Herceptin) in patients with metastatic breast cancer. II. Determine the response rate of these patients to this treatment regimen. III. Determine the median time to treatment failure in these patients with this treatment regimen. IV. Determine the incidence of cardiac toxicity in these patients with this treatment regimen. V. Assess the quality of life in these patients. PROTOCOL OUTLINE: This is a dose escalation study of capecitabine. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours on day 2; and oral capecitabine on days 3-16. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued. Quality of life is assessed at baseline and after 3 courses of treatment. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I dose escalation portion of this study. A total of 28-41 patients will be accrued for the phase II portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/59 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the breast; Metastatic disease; HER2 overexpressing tumor (2+ or 3+) - Bidimensionally measurable or evaluable disease - Hormone receptor status: Estrogen receptor positive or negative --Prior/Concurrent Therapy-- - Biologic therapy: No prior trastuzumab (Herceptin); No concurrent hematopoietic growth factors - Chemotherapy: No prior chemotherapy for metastatic disease; Prior adjuvant chemotherapy allowed (including regimens containing doxorubicin); No prior paclitaxel, 24 hour infusion fluorouracil, or capecitabine - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to 50% or more of the bone marrow - Surgery: Not specified - Other: No other concurrent experimental drugs --Patient Characteristics-- - Age: 18 to 59 - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times upper limit of normal - Renal: Creatinine less than 1.5 mg/dL - Cardiovascular: Ejection fraction at least 50% by MUGA; No history of congestive heart failure; No uncontrolled cardiac arrhythmias - Other: No other prior malignancy except squamous cell or basal cell carcinoma of the skin, noninvasive ductal carcinoma of the breast, or cervical dysplasia; No prior motor or sensory neuropathy grade 2 or higher; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancesCollichio, Study Chair, UNC Lineberger Comprehensive Cancer Center
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Additional Information:
Study ID Numbers: CDR0000068119; UNC-9904,NCI-G00-1834
Study Start Date: August 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006108
Other Stage 4 Breast Cancer Studies:
1. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
2. Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
3. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
4. Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
5. Chemotherapy and Peripheral Stem Cell Transplantation Followed by Trastuzumab in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
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