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Completed

NCT Number: NCT00614978

Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer

Objectives:

Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomideSecondary - Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate (ORR), Clinical Benefit (CB) and Duration of Response (DR)

Methodology:

Phase I, single-centre, open-label, dose-escalation study of combining lapatinib and temozolomide in HER-2 positive breast cancer patients with progressive brain metastases after surgery or radiotherapy or radiosurgery

Treatment:

Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.Sequential cohorts will be escalated in increments according to the dose escalation scheme, and determined by dose limiting toxicities.

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Key information

Conditions

Metastatic Breast Cancer Brain Diseases Brain Metastases Brain Neoplasms Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms HER2 Positive Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Jules Bordet Institute

Brussels, 1000, Belgium

About this study

Patients selection criteria:

  • age 18 - 70 years
  • Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance
  • Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive )
  • Previous chemotherapy (adjuvant and metastatic regimens) allowed
  • Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry)
  • At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI
  • Expected life-expectancy of more than 3 months
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, renal and hepatic functionsLVEF
  • LVEF 50% measured by echocardiography or MUGA scan
  • Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 70 years
  • Women with cytologically or histologically proven metastatic breast cancer with recurrent / progressive brain metastases evaluable by MRI, after standard treatment with surgery (at least 3 weeks prior) or WBRT (at least 3 weeks prior) or stereotactic RT (at least 1 week prior); or otherwise deemed as unsuitable for standard treatment in the first instance
  • Known HER-2 positive status (immunohistochemistry (IHC) 3+ Fluorescence In Situ Hybridization (FISH) positive )
  • Previous chemotherapy (adjuvant and metastatic regimens) allowed
  • Previous treatment with trastuzumab allowed (Trastuzumab to be discontinued prior to study entry)
  • At least one measurable lesion in the brain, defined as any lesion >5mm in longest dimension on T1-weighted, gadolinium-enhanced MRI
  • Expected life-expectancy of more than 3 months
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow, renal and hepatic functionsLVEF
  • LVEF >50% measured by echocardiography or MUGA scan
  • Concomitant corticosteroids and anti-convulsants for symptomatic brain metastases are allowed

Treatment and study plan

lapatinib and temozolomide

Drug

Temozolomide will be given orally for 5 days of every 28 days, at doses of either 100mg/m2/day or 150mg/m2/day or 200mg/m2/day AND Lapatinib will be given orally every day at either 1000mg/day or 1250mg/day or 1500mg/day.

Other names: Tykerb

Primary outcomes

  1. Primary - Determine the maximum tolerated dose (MTD) and evaluate the dose limiting toxicities (DLT) of combining lapatinib and temozolomide

    Time frame: 18 months

Secondary outcomes

  1. Obtain preliminary information on the clinical anti-tumor activity of lapatinib plus temozolomide on brain metastases secondary to HER-2 positive breast cancer including Objective Response Rate, Clinical Benefit and Duration of Response

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • GlaxoSmithKline
  • Schering-Plough

Registry information

Official study title

Phase 1 Study of the Combination of Lapatinib and Temozolomide for the Treatment of Progressive Brain Disease in HER-2 Positive Breast Cancer

Acronym: LAPTEM

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2008
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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