Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)

A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Pemetrexed (Alimta); Drug: Erlotinib (Tarceva)

Detailed Description

This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Alexandroupolis, Greece
    • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • Athens, Greece
    • 401 Military Hospital, Medical Oncology Unit
  • Athens, Greece
    • Air Forces Military Hospital, Dep of Medical Oncology
  • Athens, Greece
    • Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • Athens, Greece
    • IASO General Hospital of Athens, 1st Department of Medical Oncology
  • Athens, Greece
    • Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
  • Athens, Greece
    • Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
  • Piraeus, Greece
    • Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
  • Thessaloniki, Greece
    • Theagenion Anticancer Hospital of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
• Stage IIIB/IV
• Failure to prior chemotherapy
• Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
• Absence or irradiated and stable central nervous system metastatic disease.
• Life expectancy of more than 3 months
• Tissue sample desired for genomic study
• Age ≥ 18 years
• Performance status (WHO) < 3
• For patients > 65 years old: "non-frail" according to comprehensive geriatric assessment
• Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
• Presence of a reliable care giver for patients > 65 years old
• Informed consent.

Exclusion Criteria:

• Psychiatric illness or social situation that would preclude study compliance
• Other concurrent uncontrolled illness
• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Alimta	Drug: Pemetrexed (Alimta); Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles; Other Names: Alimta
Experimental: 2; Tarceva	Drug: Erlotinib (Tarceva); Erlotinib at the dose of 150 mg orally once a day continually until progression; Other Names: Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Tumor Progression	1 year TTP

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life assessment	Assessment every two cycles
Overall response rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile between the two treatment arms	Toxicity assessment on each chemotherapy cycles
Overall survival between the two treatment arms	1 year OS

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Collaborators: University Hospital of Crete
• Investigators: Principal Investigator: Lampros Vamvakas, MD, University Hospital of Crete

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 26, 2007
• First Submitted That Met QC Criteria: February 26, 2007
• First Posted (Estimate): February 27, 2007

Study Record Updates

• Last Update Posted (Estimate): August 19, 2010
• Last Update Submitted That Met QC Criteria: August 18, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Cancer; Erlotinib; Chemotherapy; Pemetrexed; Non-small-cell lung cancer
• 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; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Folic Acid Antagonists; Erlotinib Hydrochloride; Pemetrexed
• Other Study ID Numbers: CT/06.05