Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

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