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

This study has been completed.
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group Identifier:
First received: February 1, 2008
Last updated: May 20, 2011
Last verified: May 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) ] [ 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: 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
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

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00614965

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

Responsible Party: S.Aggelaki, Hellenic Oncology Research Group Identifier: NCT00614965     History of Changes
Other Study ID Numbers: CT/06.16 
Study First Received: February 1, 2008
Last Updated: May 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
second-line chemotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on May 01, 2016