Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV

Hellenic Oncology Research Group124 enrolled

Overview

This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC

Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Non Small Cell Lung Cancer

Interventions

IrinotecanDRUG

Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

CisplatinDRUG

Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

PemetrexedDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * Age 18 -75 years * Performance status (WHO) \<2 * Patients progressing after first-line docetaxel/gemcitabine treatment * Adequate bone marrow (absolute neutrophil count \>1000/mm3, platelet count \>100000/mm3, hemoglobin \> 9 gr/ mm3) * Adequate liver (bilirubin \<1.5 times upper limit of normal), renal (Creatinine clearance \> 50mg/min) and cardiac (LVEF \>50%) function * Presence of measurable disease (according to RESIST criteria) * 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 (2)

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Outcomes

Primary Outcomes

Overall Response Rate

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

Secondary Outcomes

Time to Tumor Progression

Time frame: 1-year

Overall Survival

Time frame: 1-year

Toxicity profile between the two treatment arms

Time frame: Toxicity assessment on each chemotherapy cycles

Quality of life assessment

Time frame: Assessment every two cycles

Data from ClinicalTrials.gov

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