A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors

Date de début de l'étude : 1 février 2004

Inclusion Criteria: * One of the following histologically confirmed solid tumors: * Brain tumors * Osteogenic sarcoma * Rhabdomyosarcoma * Soft tissue sarcoma (excluding Ewing's sarcoma) * Neuroblastoma * Germ cell tumors * Recurrent or refractory disease * No known curative therapy exists * Performance status - Karnofsky 50-100% (for patients age 11 to 21) * Performance status - Lansky 50-100% (for patients age 10 and under) * At least 8 weeks * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 (transfusion independent\*) * Hemoglobin \> 8.0 g/dL (transfusion allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL for patients age 5 and under * ≤ 1.0 mg/dL for patients 6 to 10 * ≤ 1.2 mg/dL for patients 11 to 15 * ≤ 1.5 mg/dL for patients age 15 to 21 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow tablets (for patients in part 2 only) * No uncontrolled infection * Recovered from all prior immunotherapy * At least 7 days since prior biologic therapy * At least 3 months since prior stem cell transplantation and no evidence of active graft-versus-host disease * More than 1 week since prior growth factors * No concurrent prophylactic growth factor therapy * No concurrent immunotherapy * No concurrent biologic therapy * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent systemic corticosteroids except for treatment of increased intracranial pressure or symptomatic tumor edema in patients with CNS tumors * No concurrent steroids as an antiemetic * Concurrent dexamethasone for patients with CNS tumors allowed provided patient has been on a stable or decreasing dose for at least 1 week before study entry * Recovered from all prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 weeks since prior substantial bone marrow irradiation * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to 50% or more of the pelvis * At least 8 weeks since prior standard-fraction radiotherapy for patients with recurrent brain tumors unless there is biopsy proof of recurrent tumor * Prior radiosurgery within the past 9 months allowed provided there is documentation of progressive disease by biopsy, positron-emission tomography (PET) scan, or MR spectroscopy * No concurrent radiotherapy * More than 1 week since prior CYP3A4 inhibitors * More than 4 weeks since prior CYP3A4 inducers * More than 5 days since prior proton-pump inhibitors * More than 2 days since prior H_2 blockers * No prior erlotinib * No concurrent enzyme-inducing anticonvulsants * No concurrent proton-pump inhibitors * No concurrent H2 blockers * No other concurrent investigational agents * Concurrent antacids allowed provided the antacid is not administered 2 hours before, during, and 2 hours after erlotinib administration