Overview

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