Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00614965

Purpose

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	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Irinotecan Drug: Cisplatin Drug: Pemetrexed	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Toxicity profile between the two treatment arms [ Time Frame: Toxicity assessment on each chemotherapy cycles ] [ Designated as safety issue: Yes ]
Quality of life assessment [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	276
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IC	Drug: Irinotecan Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles Drug: Cisplatin Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
2: Experimental PC	Drug: Cisplatin Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles Drug: Pemetrexed Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614965

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations

Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Air Forces Military Hospital, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD

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

Responsible Party:	Hellenic Oncology Research Group ( S.Aggelaki )
Study ID Numbers:	CT/06.16
Study First Received:	February 1, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00614965
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Cancer
NSCLC
second-line chemotherapy
irinotecan
pemetrexed

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Irinotecan
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009