Status:
COMPLETED
High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Lead Sponsor:
David M. Jackman, MD
Collaborating Sponsors:
AstraZeneca
Massachusetts General Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
* The standard therapy for this type of cancer is to give chemotherapy directly into the spinal fluid, usually by a spinal tap. Some chemotherapy may, in some cases, be combined with radiation. This s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00372515
Start Date
June 1 2006
End Date
April 1 2015
Last Update
January 31 2018
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115