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Evaluation of CSF Levels of Tarceva (OSI-774) in Patients With Stage III Non-Small Cell Lung Cancer and No CNS Involvement Undergoing Treatment With Tarceva


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Trial Information

Evaluation of CSF Levels of Tarceva (OSI-774) in Patients With Stage III Non-Small Cell Lung Cancer and No CNS Involvement Undergoing Treatment With Tarceva


OBJECTIVES:

- Determine the cerebrospinal fluid penetration of erlotinib in a subset of patients who
are undergoing treatment with erlotinib for stage III non-small cell lung cancer and
have no CNS metastatic disease.

OUTLINE: This is a pilot, nonrandomized study.

Patients will undergo single lumbar puncture (LP) to remove cerebrospinal fluid for
analysis.

After completion of study, patients will be monitored for 1 month after LP to assess for any
LP-related complications.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Michael A. Vogelbaum, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CASE-CCF-6503

NCT ID:

NCT00305617

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195