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

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440414
• Other study ID #: CT/06.05
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2007
• Last updated: August 18, 2010
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: August 2010
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tumor Progression		1 year TTP	No
Secondary	Overall response rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Overall survival between the two treatment arms		1 year OS	No
Secondary	Quality of life assessment		Assessment every two cycles	No
Secondary	Toxicity profile between the two treatment arms		Toxicity assessment on each chemotherapy cycles	Yes