Clinical trial NCT00440414: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Cancer
Non-small-cell lung cancer
Chemotherapy
Pemetrexed
Erlotinib
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2007-02-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to Tumor Progression
timeFrame: 1 year TTP
Secondary outcomes:
measure: Overall response rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
measure: Overall survival between the two treatment arms
timeFrame: 1 year OS
measure: Quality of life assessment
timeFrame: Assessment every two cycles
measure: Toxicity profile between the two treatment arms
timeFrame: Toxicity assessment on each chemotherapy cycles
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Department of Medical Oncology
city: Athens
country: Greece
facility: Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
city: Athens
country: Greece
facility: Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
city: Piraeus
country: Greece
facility: Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete
name: Lampros Vamvakas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Crete
name: Athanasios Karampeazis, MD
role: PRINCIPAL_INVESTIGATOR
References: