NCT00614965

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

3.3 years

First QC Date

February 1, 2008

Last Update Submit

May 20, 2011

Conditions

Non Small Cell Lung Cancer

Keywords

CancerNSCLCsecond-line chemotherapyirinotecanpemetrexed

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

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

Secondary Outcomes (4)

  • Time to Tumor Progression

    1-year

  • Overall Survival

    1-year

  • Toxicity profile between the two treatment arms

    Toxicity assessment on each chemotherapy cycles

  • Quality of life assessment

    Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

IC

Drug: IrinotecanDrug: Cisplatin

2

EXPERIMENTAL

PC

Drug: CisplatinDrug: Pemetrexed

Interventions

IrinotecanDRUG

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

Also known as: CPT-11
1
CisplatinDRUG

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

Also known as: CDDP
12
PemetrexedDRUG

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

Also known as: Alimta
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Air Forces Military Hospital, Dep of Medical Oncology

Athens, Greece

Location

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

Athens, Greece

Location

Related Publications (1)

  • 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.

    PMID: 27492015DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasms

Interventions

IrinotecanCisplatinPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Sofia Aggelaki, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

GR(2)