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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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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 CenterLebanon, New Hampshire  03756