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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Erlotinib (Tarceva)
Pemetrexed (Alimta)
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Alimta

Tarceva

Outcomes

Primary Outcome Measures

Time to Tumor Progression

Secondary Outcome Measures

Overall response rate
Overall survival between the two treatment arms
Quality of life assessment
Toxicity profile between the two treatment arms

Full Information

First Posted
February 26, 2007
Last Updated
August 18, 2010
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00440414
Brief Title
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
Official Title
A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Alimta
Arm Title
2
Arm Type
Experimental
Arm Description
Tarceva
Intervention Type
Drug
Intervention Name(s)
Erlotinib (Tarceva)
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib at the dose of 150 mg orally once a day continually until progression
Intervention Type
Drug
Intervention Name(s)
Pemetrexed (Alimta)
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
Primary Outcome Measure Information:
Title
Time to Tumor Progression
Time Frame
1 year TTP
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Title
Overall survival between the two treatment arms
Time Frame
1 year OS
Title
Quality of life assessment
Time Frame
Assessment every two cycles
Title
Toxicity profile between the two treatment arms
Time Frame
Toxicity assessment on each chemotherapy cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lampros Vamvakas, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Athanasios Karampeazis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
401 Military Hospital, Medical Oncology Unit
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
IASO General Hospital of Athens, 1st Department of Medical Oncology
City
Athens
Country
Greece
Facility Name
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
Theagenion Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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