High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 31, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- David M. Jackman, MD
- Interventions being studied
- Drug: Gefitinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 31, 2018. Always confirm current availability with the study team.