Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma
About this trial
This is an interventional treatment trial for Adult Anaplastic Astrocytoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies: Non-small cell lung Mesothelioma Breast Head and neck Esophageal Pancreatic Bladder Prostate Ovarian Anal Colorectal carcinoma Cervical carcinoma Hepatocellular carcinoma Metastatic or unresectable disease Standard curative or palliative therapy does not exist or is no longer effective Epidermal growth factor receptor (EGFR) positive Hepatic or renal dysfunction defined as one of the following: Direct bilirubin 1.0-7.0 mg/dL with any AST Albumin less than 2.5 g/dL Creatinine 2.5-5.0 mg/dL Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy Hormone receptor status: Not specified Male or female Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 See Disease Characteristics No evidence of biliary obstruction See Disease Characteristics No evidence of renal obstruction No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No gastrointestinal tract disease that would preclude ability to take oral medications No requirement for IV alimentation No active peptic ulcer disease No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrome) No prior congenital abnormality (e.g., Fuch's dystrophy) No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose) No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Fertile patients must use effective contraception No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin) No prior nitrosoureas See Disease Characteristics No concurrent steroids At least 4 weeks since prior radiotherapy At least 4 weeks since prior major surgery No prior surgical procedures affecting absorption No prior EGFR-targeting therapies, including gefitinib or Imclone C-225 At least 3 months since prior suramin More than 7 days since prior grapefruit juice More than 7 days since other prior CYP3A4 inhibitors No concurrent grapefruit juice No concurrent CYP3A4 inducers, substrates, or other inhibitors No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents No concurrent combination anti-retroviral therapy for HIV-positive patients
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.