Lapatinib & Epirubicin in Treating Patients With Metastatic Breast Cancer.

Status Completed

Clinical Trial Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with epirubicin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when given together with lapatinib in treating patients with metastatic breast cancer.

Clinical Trial Description

OBJECTIVES:

Primary

- To assess the safety and tolerability of fixed-dose lapatinib ditosylate in combination with epirubicin hydrochloride in patients with metastatic breast cancer.

- To determine the optimally-tolerated regimen in these patients.

Secondary

- To determine the clinical efficacy of this regimen in these patients.

- To analyze pharmacokinetic data of this regimen.

- To determine biomarkers that correlate with clinical benefit or response to lapatinib ditosylate in these patients.

Tertiary

- To identify tumor-derived or blood-derived biomarkers that correlate with or are predictive of clinical response or benefit to lapatinib ditosylate in these patients.

- To determine the levels of IGF-IR and phosphorylated IGF-IR in tumor tissue.

- To determine the expression pattern of the proteins associated with drug resistance that may be clinically active in these patients.

OUTLINE: This is a multicenter, dose-escalation study of epirubicin hydrochloride.

Patients receive oral lapatinib ditosylate followed by epirubicin hydrochloride IV over 15-30 minutes on day 1. Treatment repeats every 3 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacokinetic analysis via liquid chromatography-mass spectometry (LC-MS).

After completion of study therapy, patients are followed at 28 days and then every 3 months thereafter. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00753207
Study type	Interventional
Source	ICORG- All Ireland Cooperative Oncology Research Group
Contact
Status	Completed
Phase	Phase 1
Start date	October 2007
Completion date	March 2012

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lapatinib and Epirubicin in Treating Patients With Metastatic Breast Cancer. ICORG 06-30

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms