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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

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