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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Drug: Irinotecan; Drug: Cisplatin; Drug: Pemetrexed	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	124 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	November 2006
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	March 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; IC	Drug: Irinotecan; Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Other Name: CPT-11 Drug: Cisplatin; Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Other Name: CDDP
Experimental: 2; PC	Drug: Cisplatin; Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Other Name: CDDP Drug: Pemetrexed; Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles; Other Name: Alimta

Outcome Measures

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Primary Outcome Measures :

1. Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

Secondary Outcome Measures :

1. Time to Tumor Progression [ Time Frame: 1-year ]
2. Overall Survival [ Time Frame: 1-year ]
3. Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ]
4. Quality of life assessment [ Time Frame: Assessment every two cycles ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:	Sofia Aggelaki, MD	University Hospital of Crete, Dep of Medical Oncology

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	S.Aggelaki, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00614965 History of Changes
Other Study ID Numbers:	CT/06.16
First Posted:	February 14, 2008
Last Update Posted:	May 23, 2011
Last Verified:	May 2011

Keywords provided by Hellenic Oncology Research Group:

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

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Irinotecan	Cisplatin; Camptothecin; Pemetrexed; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors