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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: Erlotinib (Tarceva) (Drug); Pemetrexed (Alimta) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Lampros Vamvakas, MD, Principal Investigator, Affiliation: University Hospital of Crete
Athanasios Karampeazis, MD, Principal Investigator, Affiliation: University Hospital of Crete

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.

Clinical Details

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

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

Primary outcome: Time to Tumor Progression

Secondary outcome:

Overall response rate

Overall survival between the two treatment arms

Quality of life assessment

Toxicity profile between the two treatment arms

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

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, Greece

Additional Information

Starting date: April 2006
Last updated: August 18, 2010

Page last updated: August 20, 2015

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