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

A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00614965

Enrollment

124

Registered

2008-02-14

Start date

2006-11-30

Completion date

2010-03-31

Last updated

2011-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Cancer, NSCLC, second-line chemotherapy, irinotecan, pemetrexed

Brief summary

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

Detailed description

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.

Interventions

DRUGIrinotecan

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

DRUGCisplatin

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

DRUGPemetrexed

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary

Measure	Time frame
Time to Tumor Progression	1-year
Overall Survival	1-year
Toxicity profile between the two treatment arms	Toxicity assessment on each chemotherapy cycles
Quality of life assessment	Assessment every two cycles

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026