Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

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

Summary

Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed malignant pleural mesothelioma

• Epithelial

• Sarcomatous

• Biphasic

• Measurable or nonmeasurable disease

• Not amenable to extrapleural pneumonectomy

• No known CNS metastases

• Performance status - Zubrod 0-1

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver involvement of tumor)

• Creatinine no greater than 2 times ULN

• No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation

• No active peptic ulcer disease

• No intractable nausea or vomiting

• Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube

• No known history of the following:

• Dry eye syndrome

• Sjogren's syndrome

• Keratoconjunctivitis sicca

• Exposure keratopathy

• Fuch's dystrophy

• Other active disorders of the cornea

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No HIV-positive patients receiving combination antiretroviral therapy

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission

• No prior biologic therapy for this tumor

• No prior chemotherapy for this tumor

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy and recovered

• See Disease Characteristics

• At least 4 weeks since prior major surgery (e.g., thoracotomy or laparotomy), excluding minor surgeries (e.g., mediastinoscopy, thoracoscopy, or minor biopsies)

• Recovered from prior surgery

• No prior surgical procedures affecting absorption

• No prior investigational anticancer agents for this tumor