Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
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ClinicalTrials.gov Identifier: NCT00614965 |
Recruitment Status :
Completed
First Posted : February 14, 2008
Last Update Posted : May 23, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Irinotecan Drug: Cisplatin Drug: Pemetrexed | Phase 2 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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

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
Greece | |
Air Forces Military Hospital, Dep of Medical Oncology | |
Athens, Greece | |
IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |
Athens, Greece |
Principal Investigator: | Sofia Aggelaki, MD | University Hospital of Crete, Dep of Medical Oncology |
Responsible Party: | S.Aggelaki, Hellenic Oncology Research Group |
ClinicalTrials.gov 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 |
Cancer NSCLC second-line chemotherapy irinotecan pemetrexed |
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 |
Cisplatin Irinotecan Pemetrexed Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |