A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS) - Full Text View

Purpose

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Erlotinib [Tarceva]	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Smoking

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

To compare the efficacy of two dose levels of Tarceva on progression-free survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of 150 mg versus 300 mg Tarceva with respect to response and disease control rates, and overall survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
To assess the safety of Tarceva [ Time Frame: Throughout study (up to 3 years) ] [ Designated as safety issue: No ]
To evaluate the plasma concentrations of Tarceva [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
To assess the quality of life [ Time Frame: Questionnaire every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Erlotinib [Tarceva] 150 mg single daily oral dose until disease progression
Experimental: 2	Drug: Erlotinib [Tarceva] 300 mg single daily oral dose until disease progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients aged >/=18 years
inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
ECOG performance status 0-2
Life expectancy >/=12 weeks
Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average >/=1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

Prior antibody or small molecule therapy against EGFR
Radiotherapy within 28 days prior to enrolment
Received more than one line of chemotherapy for locally advanced/metastatic NSCLC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183858

Contacts

Contact: Please reference Study ID Number: MO22162 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Hide Study Locations

Locations

United States, Nebraska
	Completed
Omaha, Nebraska, United States, 68114
China
	Completed
Beijing, China, 100071
	Active, not recruiting
Changchun, China, 130012
	Active, not recruiting
Chengdu, China, 610041
	Active, not recruiting
Fu Zhou, China, 350014
	Active, not recruiting
Guangzhou, China, 510080
	Active, not recruiting
Nan Ning, China, 530021
	Active, not recruiting
Nanjing, China, 210009
	Active, not recruiting
Shanghai, China, 200030
	Active, not recruiting
Shanghai, China, 200433
	Active, not recruiting
Shenyang, China, 110001
	Completed
Tianjin, China, 300060
	Completed
Wuhan, China, 430030
Denmark
	Recruiting
Hillerød, Denmark, 3400
	Recruiting
København, Denmark, 2100
	Recruiting
Naestved, Denmark, 4700
	Recruiting
Roskilde, Denmark, 4000
Egypt
	Recruiting
Cairo, Egypt
	Recruiting
Cairo, Egypt, 11796
France
	Recruiting
Caen, France, 14076
	Recruiting
Cergy Pontoise, France, 95303
	Completed
Limoges, France, 87042
	Completed
Marseille, France, 13915
	Recruiting
Paris, France, 75674
	Recruiting
Paris, France, 75679
	Recruiting
Paris, France, 75908
Germany
	Recruiting
Berlin, Germany, 14165
	Completed
Berlin, Germany, 12167
	Recruiting
Essen, Germany, 45147
	Not yet recruiting
Gauting, Germany, 82131
	Recruiting
Grosshansdorf, Germany, 22927
	Recruiting
Hannover, Germany, 30659
	Recruiting
Hannover, Germany, 30625
	Recruiting
Immenhausen, Germany, 34376
	Recruiting
Lostau, Germany, 39291
	Recruiting
München, Germany, 81925
	Recruiting
Nürnberg, Germany, 90419
	Recruiting
Rheine, Germany, 48431
	Recruiting
Villingen-schwenningen, Germany, 78045
	Recruiting
Wuerselen, Germany, 52146
	Completed
Wuppertal, Germany, 42283
Netherlands
	Recruiting
Amsterdam, Netherlands, 1007 MB
	Recruiting
Breda, Netherlands, 4818 CK
	Recruiting
Nieuwegein, Netherlands, 3435 CM
	Recruiting
Zwolle, Netherlands, 8011 JW
Spain
	Completed
Barcelona, Spain, 08025
	Completed
Barcelona, Spain, 08035
	Completed
Madrid, Spain, 28041
	Active, not recruiting
Madrid, Spain, 28040
	Active, not recruiting
Málaga, Spain, 29010
	Completed
Sabadell, Spain, 08208
	Completed
Sevilla, Spain, 41013
	Active, not recruiting
Valencia, Spain, 46009
Switzerland
	Recruiting
Baden, Switzerland, 5404
	Recruiting
Basel, Switzerland, 4031
	Recruiting
Fribourg, Switzerland, 1700
Turkey
	Recruiting
Ankara, Turkey, 06000
	Recruiting
Ankara, Turkey, 06200
	Terminated
Eskisehir, Turkey, 26480
	Recruiting
Gaziantep, Turkey, 27310
	Recruiting
Izmir, Turkey, 35110
	Recruiting
Izmir, Turkey, 35340
	Completed
Konya, Turkey, 42050

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01183858 History of Changes
Other Study ID Numbers:	MO22162, 2010-018476-24
Study First Received:	August 16, 2010
Last Updated:	May 7, 2013
Health Authority:	Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013