Cerebrospinal Fluid Levels of Erlotinib in Patients Receiving Erlotinib For Stage III Non-Small Cell Lung Cancer

NCT00305617 | Completed

• 3 other identifiers: CASE-CCF-6503P30CA043703CASE-CCF-0967
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Determining whether erlotinib passes into the cerebrospinal fluid may help in planning treatment for some types of cancer. PURPOSE: This clinical trial is studying how well erlotinib is able to pass into the cerebrospinal fluid of patients receiving erlotinib for stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• CSF penetration as measured by CSF fluid via lumbar puncture on day 7 of treatment

Interventions

antitumor drug screening assay OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D. * Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week * No known CNS primary or metastatic cancer at any time prior to time of enrollment * No MRI evidence of pathological enhancement at the time of study entry PATIENT CHARACTERISTICS: * Patients must use adequate birth control measures while in the study * No significant side effects to erlotinib that require dose reduction or interruption * None of the following medical issues which could make a lumbar puncture unsafe: * Platelets \< 100,000/mm³ * INR \> 1.1 * Known bleeding dyscrasia * Absolute neutrophil count \< 1,500/mm³ * Ongoing systemic bacterial infection PRIOR CONCURRENT THERAPY: * Patients on modest or anti-epileptic therapy must be on nonenzyme-inducing drug only, including any of the following: * Neurontin * Lamictal * Depakote, Depakene * Felbatol * Keppra * Gabitril * Topimax * Zonegran * No concurrent enzyme-inducing anti-epileptic drugs such as phenytoin, carbamazepine, or phenobarbital * No concurrent other drug known to affect the metabolism of erlotinib * No concurrent anticoagulant therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Drug Screening Assays, Antitumor

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Study Officials

• Michael A. Vogelbaum, MD, PhD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Last Updated: May 17, 2011

Record last verified: 2009-07

Locations

US (1)