High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purposes of this study are to find out if using high doses of the drug Gefitinib (Iressa) as a way to treat patients with non-small cell lung cancer that has spread to the covering of the brain and/or spinal cord (meninges) results in any bad side effects; and to determine the highest dose that can be given to patients in this setting.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David M. Jackman, MD
• Collaborators: AstraZeneca; Massachusetts General Hospital
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of non-small cell lung cancer of any histologic subtype

• High likelihood of gefitinib sensitivity, as evidenced by one or more of the following: previous complete or partial response to treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor, erlotinib, or gefitinib; known somatic mutation of the EGFR tyrosine kinase

• Recurrent or persistent disease as manifested by carcinomatous meningitis

• ECOG PS 0-3

• Age 18 years or older

• Greater than 2 weeks since prior radiation therapy

• Greater than 3 weeks since prior major surgery

• Adequate hematologic, renal, and/or hepatic function

• Coagulation parameters: international normalized ratio(INR)less than or equal to 1.5 and an activated thromboplastin time < 50 seconds

Exclusion Criteria:

• Previous Grade 4 toxicity on gefitinib or erlotinib leading to dose reduction or interruption

• Uncontrolled brain metastases, or brain metastases associated with mass effect that would contraindicate lumbar puncture

• Any other malignancy within the past five years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin

• Dysphagia

• Active gastrointestinal disease or disorder that alters gastrointestinal motility or absorption

• Incomplete healing from previous oncologic or other major surgery

• Any pre-existing severe or unstable medical condition

• Any condition requiring concurrent and ongoing use of anticoagulation

• Inability to undergo collection of CSF, either by repeated lumbar puncture or placement of an Omaya reservoir

• Pregnant or breastfeeding

• Concurrent intrathecal drug administration or radiotherapy

• Concurrent systemic chemotherapy or investigational agent

• Anticoagulant except aspirin or heparin flushes

• Enzyme-inducing anti-epileptic drug

• CYP3A4 inhibitors