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

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Erlotinib (Tarceva) Drug: Pemetrexed (Alimta)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Time to Tumor Progression [ Time Frame: 1 year TTP ]

Secondary Outcome Measures:

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


Estimated Enrollment:	320
Study Start Date:	April 2006
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Alimta	Drug: Pemetrexed (Alimta) Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles Other Name: Alimta
Experimental: 2 Tarceva	Drug: Erlotinib (Tarceva) Erlotinib at the dose of 150 mg orally once a day continually until progression Other Name: Tarceva

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440414

Locations


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

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators


Principal Investigator:	Lampros Vamvakas, MD	University Hospital of Crete
Principal Investigator:	Athanasios Karampeazis, MD	University Hospital of Crete

More Information


Responsible Party:	L.Vamvakas, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00440414 History of Changes
Other Study ID Numbers:	CT/06.05
Study First Received:	February 26, 2007
Last Updated:	August 18, 2010

Keywords provided by Hellenic Oncology Research Group:


Cancer Non-small-cell lung cancer Chemotherapy Pemetrexed Erlotinib

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic	Bronchial Neoplasms Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017