Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: Cancer Research UK; Roche Pharma AG
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Advanced disease (stage IIIB or IV)

• Diagnosis within 62 days prior to randomization

• Not suitable for first-line chemotherapy, as defined by the following criteria*:

• ECOG performance status 2-3

• ECOG performance status 0-1 AND creatinine clearance < 60 mL/min

• NOTE: *These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

• Estimated life expectancy of at least 8 weeks

• Able to take oral medication

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No severe uncontrolled infection

• No unstable angina

• No myocardial infarction within the past month

• No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)

• No acute renal failure

• Bilirubin < 2 times upper limit of normal (ULN)

• Transaminases < 2 times ULN (5 times ULN if liver metastases are present)

• Creatinine < 5 times ULN

• No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications

• No other prior or current malignant disease likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

• No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)

• No prior palliative radiotherapy

• Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks

• No concurrent cyclooxygenase-2 inhibitors