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

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Pemetrexed (Alimta); Drug: Erlotinib (Tarceva)

• Registration Number: NCT00440414
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-18
• Last Update Posted: 2010-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pemetrexed (Alimta)	Alimta
2	Erlotinib (Tarceva)	Tarceva

Primary Outcome Measures

Name	Time	Method
Time to Tumor Progression	1 year TTP

Secondary Outcome Measures

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

Trial Locations

Locations (9)

IASO General Hospital of Athens, 1st Department of Medical Oncology; 🇬🇷 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

Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

Theagenion Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece

Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases; 🇬🇷 Athens, Greece

401 Military Hospital, Medical Oncology Unit; 🇬🇷 Athens, Greece