Status:
COMPLETED
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Roche Pharma AG
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-s...
Detailed Description
OBJECTIVES: Primary * Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo. Secondary * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT00275132
Start Date
April 1 2005
End Date
April 1 2009
Last Update
December 3 2014
Active Locations (1)
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1
London Lung Cancer Group
London, England, United Kingdom, NW1 2ND