753207
Last Update Posted: 2016-02-15
Recruiting has ended
Females accepted | 18 Years-120 Years |
10 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Lapatinib and Epirubicin in Treating Patients With Metastatic Breast Cancer. ICORG 06-30
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.
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.
Eligibility
Relevant conditions:
Breast Cancer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov