NCT01427322

Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease

A Randomized Study of Lapatinib With Radiation Versus Radiation Alone in Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lapatinib will prevent radiation-induced increase in Transforming Growth Factor alpha (TGFα), an important growth factor in cancer cell recovery after ionizing irradiation.

Detailed description

Lapatinib is an orally bioavailable small molecule inhibitor of ERBB1 and ERBB2 (HER2). It is currently indicated for use in patients with HER2 over-expressing metastatic breast cancer. Serum increases in TGFα can have growth potentiating effects on distant sites of metastatic disease. Palliative irradiation paradoxically may promote distant tumor growth; blocking shedding of TGFα from irradiated tumors may prevent this effect and improve the therapeutic index of radiation therapy.

Conditions

• Epithelial Cancer

Interventions

Type	Name	Description
DRUG	Lapatinib	given orally 2-4 hours before first fraction of radiation therapy
RADIATION	Radiation therapy	Standard radiation therapy

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2011-09-01
• Last updated: 2015-07-08

Locations

2 sites across 1 country: United States