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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer Research UK
Roche Pharma AG
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00275132
First received: January 10, 2006
Last updated: December 9, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Lung Cancer
 Drug: erlotinib hydrochloride
Drug: Matched placebo
 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 Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Overall survival [ Time Frame: between date of randomisation and date of death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death. ] [ Designated as safety issue: No ]
  • Adverse events/Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: between randomisation and 8 weeks. ] [ Designated as safety issue: No ]
    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).

  • Cost-effectiveness [ Time Frame: from date of randomisation to death ] [ Designated as safety issue: No ]
    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.


Enrollment: 670
Study Start Date: April 2005
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Tarceva (OSI-774, erlotinib) PO 150mg daily
 Drug: erlotinib hydrochloride
Tarceva (OSI-774, erlotinib) PO 150 mg daily
Other Names:
  • OSI-774
  • Tarceva
Placebo Comparator: Matched placebo
Matched placebo PO daily
 Drug: Matched placebo
Matched placebo PO daily

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

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275132

Locations
United Kingdom
London Lung Cancer Group
London, England, United Kingdom, NW1 2ND
Sponsors and Collaborators
University College, London
Cancer Research UK
Roche Pharma AG
Investigators
Study Chair: Siow M Lee, MD, PhD, FRCP University College London Hospitals
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00275132     History of Changes
Other Study ID Numbers: CDR0000457755, LLCG-TOPICAL, EU-20313, ISRCTN, Cancer Research UK (CTAAC), Roche AG Pharma, UCL Trial Sponsor reference, EudraCT number
Study First Received: January 10, 2006
Last Updated: December 9, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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 23, 2013