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

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 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:

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

U.S. FDA Resources

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 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


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

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, see Learn About Clinical Studies.

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

No publications provided


Responsible Party:	S.Aggelaki, Hellenic Oncology Research Group
ClinicalTrials.gov 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:


Cancer NSCLC second-line chemotherapy irinotecan pemetrexed

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Cisplatin Irinotecan Pemetrexed	Antimetabolites 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

ClinicalTrials.gov processed this record on March 03, 2015