Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/Neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

NCT00068757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-09-12

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining lonafarnib and trastuzumab with paclitaxel may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when given together with trastuzumab and paclitaxel in treating patients with HER2/neu-overexpressing stage IIIB, stage IIIC, or stage IV breast cancer.

Conditions

Interventions

BIOLOGICAL

trastuzumab

DRUG

lonafarnib

DRUG

paclitaxel

OTHER

pharmacological study

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Jan H. M. Schellens, MD, PhD · The Netherlands Cancer Institute

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2007-11-30

Countries

  • Belgium
  • France
  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00068757 on ClinicalTrials.gov