Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression
18 Years
N/A
Both
Breast Cancer
Trial Information
Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression
OBJECTIVES:
- 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.
- Determine the pharmacokinetic and pharmacodynamic profiles of this regimen in this
patient population.
- Determine the objective response rate of patients treated with this regimen.
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.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Peter A. Kaufman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068543
NCT ID:
NCT00014430
Start Date:
November 1999
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
