Status:
WITHDRAWN
Stereotactic Radiosurgery and Erlotinib in Treating Patients With Non-Small Cell Lung Cancer and Brain Metastases
Lead Sponsor:
University of California, San Francisco
Conditions:
Lung Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiosurgery may...
Detailed Description
OBJECTIVES: Primary * To determine the acute as well as long-term toxicity (especially grade III neurotoxicity) of concurrent erlotinib hydrochloride and single-fraction radiosurgery in patients wit...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC) meeting the following criteria:
- Fewer than 5 intraparenchymal brain metastases by gadolinium-enhanced MRI meeting the following criteria:
- Maximum diameter ≤ 4.0 cm
- If multiple lesions are present and one lesion is \> 3.0 cm, the remaining lesions must be ≤ 3.0 cm in maximum diameter
- No metastases within 3 mm of the optic nerve or optic chiasm such that some portion of the optic nerve or chiasm would receive \> 9 Gy from radiosurgery
- No metastases in the brainstem, midbrain, pons, or medulla
- No prior complete resection of a single brain metastasis or of all known brain metastases
- Subtotal resection allowed provided residual disease is ≤ 4.0 cm in maximum diameter
- No clinical or radiographic evidence of unstable systemic progression (other than the study lesion\[s\]) within the past month
- Patients with brain metastases at initial presentation do not require 1 month of scans documenting stable disease
- Isolated brain metastases with stable systemic disease allowed
- No leptomeningeal metastases by MRI and/or positive cerebrospinal fluid cytology
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 3 months
- ANC \> 1,000/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 10 g/dL
- PT and PTT normal
- AST \< 2 times upper limit of normal (ULN)
- Alkaline phosphatase \< 2 times ULN
- Total bilirubin \< 2 times ULN
- Lactic dehydrogenase \< 2 times ULN
- Serum creatinine \< 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy
- Neurologic function status 0-2
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride
- No contraindication to MRI (e.g., cardiac pacemaker)
- No absolute contraindication to lumbar puncture
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior systemic therapy allowed
- No prior cranial radiotherapy
- Prior radiotherapy to noncranial sites allowed
- More than 1 week since prior intrathecal chemotherapy or prior treatment of leptomeningeal carcinoma
- No concurrent systemic therapy
- Prior or current erlotinib hydrochloride for treatment of systemic disease allowed provided systemic disease has not progressed while on erlotinib hydrochloride
- No concurrent enzyme-inducing anticonvulsant
- If patients are on an enzyme-inducing anticonvulsant (e.g., phenytoin, carbamazepine, or phenobarbital), the agent must be converted to a nonenzyme-inducing anticonvulsant before or at the start of erlotinib hydrochloride treatment
- No concurrent CYP3A4 inhibitors or inducers (e.g., Hypericum perforatum \[St. John wort\] or ketoconazole)
- No other concurrent investigational therapy
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00738335
Start Date
January 1 2009
End Date
July 1 2009
Last Update
October 4 2012
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115