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

Lung Cancer Clinical Trial

— TOPICAL  

Official title:

A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275132
• Other study ID #: CDR0000457755
• Secondary ID: LLCG-TOPICALEU-2
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2006
• Last updated: December 1, 2014
• Start date: April 2005
• Est. completion date: April 2009

Study information

• Verified date: December 2011
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

• Compare progression-free survival and response rate.

• Compare toxicity.

• Compare the quality of life.

• Compare cost-effectiveness.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral erlotinib once daily for up to 24 months.

• Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• erlotinib hydrochloride
Tarceva (OSI-774, erlotinib) PO 150 mg daily
• Matched placebo
Matched placebo PO daily

Locations

Country	Name	City	State
United Kingdom	London Lung Cancer Group	London	England

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Cancer Research UK, Roche Pharma AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		between date of randomisation and date of death from any cause	No
Secondary	Progression free survival		from the date of randomisation to the date of first clinical evidence of progressive disease, or death.	No
Secondary	Adverse events/Toxicity		during and for 28 days following Tarceva/placebo treatment	Yes
Secondary	Quality of life	QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).	between randomisation and 8 weeks.	No
Secondary	Cost-effectiveness	Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.	from date of randomisation to death	No