NCT00284778

Brief Summary

The indication of chemotherapy of 2nd line treatment in advanced non small cell lung cancer is now well established. The two treatments of reference are pemetrexed (alimta) and docetaxel (taxotere). Effectiveness and toxicity of the two drugs are largely documented in the literature. Economic analyses are currently one of the criteria used in medical decision, beside effectiveness, quality of life and toxicities. However, Economical comparison shows significant variations in the acquisition costs of the two drugs. Consequently, it appears interesting to carry out a randomized prospective study with on exclusive economical criteria of judgment. As there is no difference in the effectiveness between the two treatments, a cost-minimization analysis will be carried out to appreciate the ratio benefit/risks from an economical point of view (payer).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

Geographic Reach
1 country

18 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

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 24, 2025

Status Verified

March 1, 2010

Enrollment Period

3.8 years

First QC Date

January 31, 2006

Last Update Submit

July 21, 2025

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

lung cancersecond line treatmentcost-minimization trialPharmaco-economic studydocetaxelpemetrexed

Study Arms (2)

ALIMTA

EXPERIMENTAL
Drug: Alimta®

Docetaxe

ACTIVE COMPARATOR
Drug: Taxotere®

Interventions

Alimta®DRUG
ALIMTA
Taxotere®DRUG
Docetaxe

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
  • Metastatic relapses allowed if asymptomatic.
  • Progressive disease during or after a standard first line platinum-based chemotherapy (without taxotere or alimta)
  • Only one chemotherapeutic line including adjuvant and neo adjuvant treatment.
  • Irradiation allowed if \< 25% bone medulla . It may be ended 2 weeks before the second line treatment.
  • At least one measurable target lesion according to recist criteria in non previously irradiated area.
  • Performance status \<=2
  • Age between 18 and 70 years
  • Life expectancy \> 12 weeks.
  • Normal hepatic function
  • Normal renal function
  • Normal serum calcium
  • Absolute neutrophil count\>1.5 gigal/l,platelets\>100 gigal/l,haemoglobin\>9.0 g/dl
  • Written informed consent

You may not qualify if:

  • SCLC, bronchioli-alveolar and neuro-endocrine carcinoma.
  • Symptomatic brain metastases.
  • Superior vena cava syndrome.
  • Uncontrolled fluid retention in the third space (pleural or ascitic collection)
  • Prior chemotherapy without platin
  • Other concomitant diseases: heart failure, angina pectoris, tachyarrythmia, recent myocardial infarction, active infections.
  • Peripheral neuropathy grade ≥ 2.
  • Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
  • Hypersensitivity to docetaxel or polysorbate 80.
  • Unability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids.
  • Pregnancy or breast feeding.
  • Follow-up of the patient impossible.
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Service de Pneumologie, CHU Angers

Angers, 49033, France

Location

Service de pneumologie; Centre Hospitalier d'Annecy

Annecy, 74011, France

Location

Service de Pneumologie; Centre Hospitalier

Beauvais, 60 021, France

Location

Service de Pneumologie ; Centre hospitalier

Charleville-Mézières, 08 000, France

Location

Service de Pneumologie; Centre Hospitalier

Draguignan, 83300, France

Location

Service de Pathologie Respiratoire; CHU de Limoges

Limoges, 87000, France

Location

Service de Pneumologie; Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

Mantes-la-Jolie, 78200, France

Location

Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

Marseille, 13274, France

Location

Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris

Paris, 75181, France

Location

Service de Pneumologie - Hôpital St Antoine, Paris

Paris, 75571, France

Location

Service de Pneumologie ; Hôpital saint Antoine, Paris

Paris, France

Location

Service de Pneumologie-Allergologie; Centre Hospitalier Général

Périgueux, 24019, France

Location

Service de Pneumologie; CHG de Roanne

Roanne, 42300, France

Location

Clinique Pneumologique; Hôpital Charles Nicolle

Rouen, 76031, France

Location

Service de Pneumologie; Hôpital Bois Guillaume

Rouen, 76233, France

Location

Service d'Oncologie Médicale; Clinique Sainte Marguerite

Toulon, 83000, France

Location

Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne

Toulon Naval, 83800, France

Location

Related Publications (1)

  • Vergnenegre A, Corre R, Berard H, Paillotin D, Dujon C, Robinet G, Crequit J, Bota S, Thomas P, Chouaid C; 0506 GFPC Team. Cost-effectiveness of second-line chemotherapy for non-small cell lung cancer: an economic, randomized, prospective, multicenter phase III trial comparing docetaxel and pemetrexed: the GFPC 05-06 study. J Thorac Oncol. 2011 Jan;6(1):161-8. doi: 10.1097/JTO.0b013e318200f4c1.

    PMID: 21150465RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

PemetrexedDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Alain Vergnenegre, MD

    CHU Limoges

    PRINCIPAL INVESTIGATOR

  • Christos Chouaid, MD

    Hôpital Saint Antoine; Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 24, 2025

Record last verified: 2010-03

Locations

FR(18)