Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer - Full Text View

Sponsor:	Norris Cotton Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014430

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Biological: trastuzumab Drug: vinorelbine ditartrate	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Trastuzumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014430

Locations

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

Sponsors and Collaborators

Norris Cotton Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter A. Kaufman, MD

Norris Cotton Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068543, DMS-9904, NCI-G01-1932
Study First Received:	April 10, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00014430 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Vinblastine
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Vinorelbine
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009