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

NCT00275132 | Completed Phase 3 DMC

• 8 other identifiers: CDR0000457755LLCG-TOPICALEU-20313ISRCTNCancer Research UK (CTAAC)Roche AG PharmaUCL Trial Sponsor referenceEudraCT number
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  between date of randomisation and date of death from any cause

Secondary Outcomes (4)

• Progression free survival

  from the date of randomisation to the date of first clinical evidence of progressive disease, or death.

• Adverse events/Toxicity

  during and for 28 days following Tarceva/placebo treatment

• Quality of life

  between randomisation and 8 weeks.

• Cost-effectiveness

  from date of randomisation to death

Study Arms (2)

Erlotinib

EXPERIMENTAL

Tarceva (OSI-774, erlotinib) PO 150mg daily

Drug: erlotinib hydrochloride

Matched placebo

PLACEBO COMPARATOR

Matched placebo PO daily

Drug: Matched placebo

Interventions

erlotinib hydrochloride DRUG

Tarceva (OSI-774, erlotinib) PO 150 mg daily

Also known as: OSI-774, Tarceva

Erlotinib

Matched placebo DRUG

Matched placebo PO daily

Matched placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

London Lung Cancer Group

London, England, NW1 2ND, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Siow M Lee, MD, PhD, FRCP

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: April 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 3, 2014

Record last verified: 2011-12

Locations

GB (1)