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

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00440414

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 III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed disodium Pemetrexed Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Overall survival between the two treatment arms [ Time Frame: 1 year survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
Time to tumor progression [ Time Frame: 1 year TTP ] [ Designated as safety issue: No ]
Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
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

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

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+302810392987	maurakh@gmail.com

Locations

Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athina Aggelidou, MD
Principal Investigator: Anna Xrhstou, MD
Principal Investigator: Ourania Anagnostopoulou, MD
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases	Recruiting
Athens, Greece
Contact: George Tavoularis, MD +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Foteini Apostolopoulou, MD
Principal Investigator: Vassilis Xandrinos, MD
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: George Tavoularis, MD +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis, MD +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology	Recruiting
Piraeus, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
401 Military Hospital, Medical Oncology Unit	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalambos Christophillakis, MD
Air Forces Military Hospital, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Kakolyris, MD
Theagenion Anticancer Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD

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:	Hellenic Oncology Research Group ( L.Vamvakas )
Study ID Numbers:	CT/06.05
Study First Received:	February 26, 2007
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00440414
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Cancer
Non-small-cell lung cancer
Chemotherapy
Pemetrexed
Erlotinib

Study placed in the following topic categories:

Folic Acid
Erlotinib
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

Folic Acid Antagonists
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009