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Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer



Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer

For Condition: stage 3B breast cancer,stage 3A breast cancer,stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Norris Cotton 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. PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of vinorelbine in combination with trastuzumab (Herceptin) in patients with HER-2/neu overexpressing unresectable or metastatic non-small cell lung cancer (closed to accrual as of 4/16/01) or refractory locally advanced or metastatic breast cancer. II. Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this patient population. III. Determine the objective response rate of patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study of vinorelbine. Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8, and trastuzumab (Herceptin) IV over 30-90 minutes on days 8 and 15 of course 1 and days 1, 8, and 15 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 30-35 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed unresectable or metastatic non-small cell lung cancer; Stage IIIB or IV (closed to accrual as of 4/16/01) OR Histologically confirmed locally advanced breast cancer that has progressed after first-line chemotherapy or metastatic breast cancer - HER-2/neu overexpression (1+ to 3+) - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior trastuzumab (Herceptin) - Chemotherapy: See Disease Characteristics; No prior vinorelbine - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Menopausal status: Not specified - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); ALT no greater than 3 times ULN - Renal: Creatinine no greater than 2 times ULN - Cardiovascular: No prior or concurrent unstable angina; No prior symptomatic congestive heart failure; No myocardial infarction within the past 6 months; LVEF at least 45% by echocardiogram or MUGA if received prior anthracycline or anthrapyrazole therapy - Other: No prior hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of these products; No other medical illness that would preclude study; Not pregnant or nursing; Negative pregnancy test Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PeterKaufman,  Study Chair,  Norris Cotton Cancer Center

Norris Cotton Cancer Center
Lebanon,  New Hampshire,  03756-0002
United States
 


Additional Information:
Study ID Numbers:  CDR0000068543;  NCI-G01-1932,DMS-9904
Study Start Date: June 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014430

Other Stage 3b Breast Cancer Studies:
1. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

2. Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer

3. Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer

4. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer

5. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

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Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer
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