Clinical trial NCT00614965: Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Cancer
NSCLC
second-line chemotherapy
irinotecan
pemetrexed
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-02-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes:
measure: Time to Tumor Progression
timeFrame: 1-year
measure: Overall Survival
timeFrame: 1-year
measure: Toxicity profile between the two treatment arms
timeFrame: Toxicity assessment on each chemotherapy cycles
measure: Quality of life assessment
timeFrame: Assessment every two cycles
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dep of Medical Oncology
city: Athens
country: Greece
facility: IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Sofia Aggelaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kentepozidis N, Economopoulou P, Christofyllakis C, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou C, Georgoulias V, Kotsakis A. Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG). Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4.