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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614965
First Posted: February 14, 2008
Last Update Posted: May 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
  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 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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) ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 124
Study Start Date: November 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614965


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: S.Aggelaki, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00614965     History of Changes
Other Study ID Numbers: CT/06.16
First Submitted: February 1, 2008
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