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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Alimta

Group Type EXPERIMENTAL

Pemetrexed (Alimta)

Intervention Type DRUG

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

2

Tarceva

Group Type EXPERIMENTAL

Erlotinib (Tarceva)

Intervention Type DRUG

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

Interventions

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Erlotinib (Tarceva)

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

Intervention Type DRUG

Pemetrexed (Alimta)

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

Intervention Type DRUG

Other Intervention Names

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Tarceva Alimta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No