Erlotinib as First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00452075
First received: March 23, 2007
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for response.

An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1 will accrue 10 patients, if less than 1 response is observed the study will stop; if more than 1 response is observed the accrual will continue up till 29 patients. A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib and Predictive Markers as First-Line Treatment of Advanced Non-Small Cell Lung Cancer for Patients Unfit for Chemotherapy

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Disease control rate [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the tolerability and safety of erlotinib in patients, who can not receive chemotherapy, by registration of side-effects. [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Correlation of EGFR expression rate and FISH potentially predictive for response [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: March 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1 medicine
erlotinib daily
Drug: erlotinib
150mg daily
Other Name: tarceva

  Eligibility

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

Inclusion Criteria:

  • Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  • Chemo-naïve patients.
  • Patients who are in the investigator's opinion not medically suitable for chemotherapy.
  • Measurable disease according to the RECIST criteria.
  • ECOG performance status of 0 - 3.
  • Life expectancy of at least 12 weeks.
  • Patients must be able to take oral medication.
  • Serum calcium within normal ranges
  • ≥ 4 weeks since prior surgery or radiation therapy
  • For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
  • 18 years of age or older
  • Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

  • Prior systemic antitumor therapy
  • Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN.
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Nursing mothers or pregnant woman.
  • Hypersensitivity to Tarceva or co-formulants.
  • Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
  • Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452075

Contacts
Contact: Helle Pappot, MD, DMSc 004535458747 pappot@rh.regionh.dk
Contact: Gedske Daugaard, MD, DMsc 004535453545 gedske@rh.regionh.dk

Locations
Denmark
Department of Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Helle Pappot, MD, DMSc    0035458747    pappot@rh.regionh.dk   
Principal Investigator: Helle Pappot, MD, DMSc         
Department of Oncology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Olfred Hansen, MD         
Principal Investigator: Olfred Hansen, MD         
Department of Oncology, Århus University Hospital Not yet recruiting
Århus, Denmark, 8000
Contact: Peter Meldgaard, MD         
Principal Investigator: Peter Melsdgaard         
Sponsors and Collaborators
Rigshospitalet, Denmark
Hoffmann-La Roche
Investigators
Principal Investigator: Pappot Helle, MD, DMSC Department of Oncology, Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Helle Pappot, MD, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00452075     History of Changes
Other Study ID Numbers: ML 20539
Study First Received: March 23, 2007
Last Updated: February 6, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
EGFR expression
erlotinib

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 April 14, 2014