U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II

Pts must have a cytologic or histologic dx of malignant peripheral nerve sheath tumor (malignant schwannoma or neurofibrosarcoma) and clinical evidence of dz that is unresectable or metastatic. Pts w/ known CNS metastasis are not elig. Pre-tx path materials must be submitted for path review and EGFR assessment. Pts must have measurable dz. X-rays, scans, ultrasound or PEs used for measurable dz must have been performed w/i 28 days prior to reg. X-rays, scans, ultrasound or PEs used for non-measurable dz must have been performed w/i 42 days prior to reg. Pts must have PS 0 – 2. Pts must not have received prior chemo, biologic therapy or any other investigational drug for this malignancy w/i 28 days prior to reg; pts must not have received any prior EGFR-targeting therapy. Pts not be receiving current concomitant RT. If pts have received prior RT, embolization, RFA to the target lesion, it must be greater than 60 days since the completion of tx and lesion must have demonstrated progression following completion of therapy. Prior srg is allowed w/ at least 3 weeks elapsing since prior major srg and pt must have recovered from all effects. Pts must have adequate hepatic, renal, and hematopoietic function. Pts w/ known hx of dry eye syndrome, Sjogren’s syndrome, keratoconjunctivitis sicca, exposure keratopathy, fuch’s dystrophy or other active disorders of the cornea are not elig. Pts known to be HIV- positive and receiving anti-retroviral therapy are not elig. Pts must not have GI tract dz resulting in the inability to take oral meds or requirement for IV alimentation, prior srg procedure affecting absorption, or active peptic ulcer dz. Pts must be able to swallow and/or receive enteral meds via gastrostomy tube. Pregnant or nursing women may not partipate.