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

Completed · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00372515

Run by

David M. Jackman, MD

People needed

7

Starts

2006-06-01

Expected to finish

2015-04-01

Last updated by the study team

2018-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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