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

NCT00440414 | Completed Phase 3

• 1 other identifier: CT/06.05
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 9

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Cancer; Non-small-cell lung cancer; Chemotherapy; Pemetrexed; Erlotinib

Outcome Measures

Primary Outcomes (1)

• Time to Tumor Progression

  1 year TTP

Secondary Outcomes (4)

• Overall response rate

  Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

• Overall survival between the two treatment arms

  1 year OS

• Quality of life assessment

  Assessment every two cycles

• Toxicity profile between the two treatment arms

  Toxicity assessment on each chemotherapy cycles

Study Arms (2)

1

EXPERIMENTAL

Alimta

Drug: Pemetrexed (Alimta)

2

EXPERIMENTAL

Tarceva

Drug: Erlotinib (Tarceva)

Interventions

Erlotinib (Tarceva) DRUG

Erlotinib at the dose of 150 mg orally once a day continually until progression

Also known as: Tarceva

2

Pemetrexed (Alimta) DRUG

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles

Also known as: Alimta

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (9)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

IASO General Hospital of Athens, 1st Department of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases

Athens, Greece

Location

Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases

Athens, Greece

Location

Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology

Piraeus, Greece

Location

Theagenion Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Erlotinib Hydrochloride; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Lampros Vamvakas, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

• Athanasios Karampeazis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: April 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

GR (9)