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

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. Identifier: NCT00614965
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : May 23, 2011
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

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.

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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
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

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 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00614965

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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
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Principal Investigator: Sofia Aggelaki, MD University Hospital of Crete, Dep of Medical Oncology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: S.Aggelaki, Hellenic Oncology Research Group Identifier: NCT00614965    
Other Study ID Numbers: CT/06.16
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Keywords provided by Hellenic Oncology Research Group:
second-line chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors