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

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00440414
First received: February 26, 2007
Last updated: August 18, 2010
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
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:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time to Tumor Progression [ Time Frame: 1 year TTP ] [ 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 ]
  • Overall survival between the two treatment arms [ Time Frame: 1 year OS ] [ 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: 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
Genders Eligible for Study:   Both
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
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens, Greece
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
401 Military Hospital, Medical Oncology Unit
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
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

No publications provided

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
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Cancer
Non-small-cell lung cancer
Chemotherapy
Pemetrexed
Erlotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014