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Sponsored by: |
VU University Medical Center |
Information provided by: | VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT00536861 |
Lung cancer is a leading cause of death worldwide. Brain metastases manifest as the first site of disease failure in between 15-30% of patients with non-small cell lung cancer (NSCLC). The standard treatment for patients with multiple brain metastases is whole brain radiotherapy but this results in only a modest survival of 3-6 months. Drugs that can enhance the effect of cranial irradiation (radiosensitizers) may improve the the response rates. Erlotinib (Tarceva) is an oral agent that has been registered for treatment in patients with metastatic NSCLC. Erlotinib has shown tumor activity in patients presenting with brain metastases, and preclinical studies show that it may be a radiosensitizer. As a prelude to studies investigating the combination of Erlotinib and cranial radiotherapy, the present study will be performed to evaluate the safety of combining both these treatments.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer Brain Metastases |
Drug: erlotinib |
Phase I |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Erlotinib Erlotinib hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Radiotherapy Concurrent With Erlotinib (Tarceva®) in the Treatment of Brain Metastases From Non-Small Cell Lung Cancer (NSCLC) |
Enrollment: | 11 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: erlotinib
Level 1 : erlotinib 100 mg/day from day -7 to the time of completion of 10 fractions of cranial irradiation, followed by 150 mg/day until disease progression or toxicity Level 2 : erlotinib 150 mg/day from day -7 before cranial irradiation, followed by 150 mg/day until disease progression or toxicity |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |||||
VU University Medical Center | |||||
Amsterdam, Netherlands, 1007 MB |
VU University Medical Center |
Study Chair: | Suresh Senan, MD, PhD | VU University Medical Center |
Principal Investigator: | Frank J Lagerwaard, MD, PhD | VU University Medical Center |
Principal Investigator: | Egbert F Smit, MD, PhD | VU University Medical Center |
Responsible Party: | VU Medical Center ( Professor S Senan ) |
Study ID Numbers: | VUMC 2005/177 |
First Received: | September 27, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00536861 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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