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

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Irinotecan

Cisplatin

Pemetrexed

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Cancer, NSCLC, second-line chemotherapy, irinotecan, pemetrexed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Air Forces Military Hospital, Dep of Medical Oncology
IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Time to Tumor Progression

Overall Survival

Toxicity profile between the two treatment arms

Quality of life assessment

Full Information

NCT ID

NCT00614965

First Posted

February 1, 2008

Last Updated

May 20, 2011

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00614965

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Cancer, NSCLC, second-line chemotherapy, irinotecan, pemetrexed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

CPT-11

Intervention Description

Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta

Intervention Description

Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles

Primary Outcome Measure Information:

Title

Overall Response Rate

Time Frame

Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measure Information:

Title

Time to Tumor Progression

Time Frame

1-year

Title

Overall Survival

Time Frame

1-year

Title

Toxicity profile between the two treatment arms

Time Frame

Toxicity assessment on each chemotherapy cycles

Title

Quality of life assessment

Time Frame

Assessment every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sofia Aggelaki, MD

Organizational Affiliation

University Hospital of Crete, Dep of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Air Forces Military Hospital, Dep of Medical Oncology

City

Athens

Country

Greece

Facility Name

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

City

Athens

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

27492015

Citation

Kentepozidis N, Economopoulou P, Christofyllakis C, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou C, Georgoulias V, Kotsakis A. Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG). Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4.

Results Reference

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

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