- - Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest
dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- - Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS)
in addition to WBRT will also be eligible.
- - Life expectancy of >12 weeks.
- - Karnofsky Performance Status (KPS) ≥ 70%.
- - Creatinine ≤2.0 times the upper limit of normal.
- - Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to enrollment, must be non-lactating and must agree to use
adequate contraception prior to enrollment and for the duration of study
- - No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation
Please note: there is no washout period required for trastuzumab, pertuzumab,
for patients who have developed new parenchymal brain metastases while on these
- - Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it
is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of
enrollment, to show that no other leptomeningeal metastases is present) and is not the
only metastasis present in the brain.
- - Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury
within 4 weeks of randomization.
- - Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy,
surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib,
and protocol-specified whole-brain radiotherapy.
- - Use of any investigational drug within 30 days or 5 half-lives, whichever is longer,
- - Inability to comply with protocol and /or not willing or not available for follow-up
- - Any condition which in the investigator's opinion makes the patient unsuitable for the
- - Patient is incontinent of urine or stool (which would make them unable to tolerate
lying still for 60 minutes).
- Known allergic reaction to Gd-DTPA
- Renal insufficiency with recent (<3 month old) creatinine >2.0