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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: erlotinib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Oncology, Rigshospitalet
  • Odense, Denmark, 5000
    • Department of Oncology, Odense University Hospital
  • Århus, Denmark, 8000
    • Department of Oncology, Århus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: arm 1 medicine; erlotinib daily	Drug: erlotinib; 150mg daily; Other Names: tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease control rate	2010

Secondary Outcome Measures

Outcome Measure	Time Frame
To investigate the tolerability and safety of erlotinib in patients, who can not receive chemotherapy, by registration of side-effects.	2010
Correlation of EGFR expression rate and FISH potentially predictive for response	2010

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: Pappot Helle, MD, DMSC, Department of Oncology, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 23, 2007
• First Submitted That Met QC Criteria: March 23, 2007
• First Posted (Estimate): March 26, 2007

Study Record Updates

• Last Update Posted (Estimate): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: erlotinib; EGFR expression
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ML 20539