Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer

NCT00014430 | Completed Phase 1

• 4 other identifiers: CDR0000068543P30CA023108DMS-9904NCI-G01-1932
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Interventions

trastuzumab BIOLOGICAL

Trastuzumab (INN; trade name Herceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers. The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell to inside the cell, and turn genes on and off. The HER proteins regulate cell growth, survival, adhesion, migration, and differentiation-functions that are amplified or weakened in cancer cells. In some cancers, notably some breast cancers, HER2 is over-expressed, and causes breast cells to reproduce uncontrollably.

Also known as: herceptin

vinorelbine ditartrate DRUG

Vinorelbine (trade name Navelbine) is an anti-mitotic chemotherapy drug that is given as a treatment for some types of cancer, including breast cancer and non-small cell lung cancer.

Also known as: Navelbine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Peter A. Kaufman, MD

  Norris Cotton Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: February 16, 2004
• Study Start: November 1, 1999
• Primary Completion: September 1, 2002
• Last Updated: March 14, 2013

Record last verified: 2002-11

Locations

US (1)