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Pharmaco-Economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer

This study is currently recruiting participants.
Verified by University Hospital, Limoges, June 2007

Sponsors and Collaborators: University Hospital, Limoges
Groupe Francais De Pneumo-Cancerologie
Information provided by: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00284778
  Purpose

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).


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Alimta®
Drug: Taxotere®
Phase III

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Docetaxel    Pemetrexed disodium    Pemetrexed   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   A Randomized Cost-Minimization Trial Comparing Pemetrexed (Alimta®) Versus Docetaxel (Taxotere®) as Second Line Treatment in Advanced Non Small Cell Lung Cancer (NSCLC): Study 05-06 of Groupe Français de Pneumo-Cancérologie (GFPC).

Further study details as provided by University Hospital, Limoges:

Estimated Enrollment:   150
Study Start Date:   February 2006

Detailed Description:

The main objective of this trial is of to compare, economically, the use of pemetrexed (alimta®) in 2nd line chemotherapy in advanced non-small cell lung cancer versus docetaxel (taxotere®).

150 patients will be selected for this trial which, after checking the eligibility criteria, will be randomized in two arms:

  • Arm A: Taxotere 75 mg/m² every 3 weeks.
  • Arm B : Alimta 500 mg/m² every 3 weeks.

Inclusion assessment.

  • Clinical signs
  • Blood cell count, renal and hepatic function (within 8 days)
  • Chest X ray, CT scan or MRI scan, abdominal echography, and/or abdominal scan (within 28 days)
  • Brain scan, bone scintigraphy and/or bone x ray (within 28 days)
  • Bronchial endoscopy (within 28 days)
  • EKG, echocardiography according to history

Follow-up assessment.

  1. At each cycle

    • Clinical signs
    • Blood cell count at D1, D8, D15
    • Creatinine, serum electrolytes (K+, Ca++ ), SGOT, SGPT, total bilirubin, LDH, alkaline phosphate, total protein and albumin, EKG, Chest X-ray at D1
  2. Follow-up each 2 months till PD
  3. End of trial: Complete tumor assessment
  4. Each objective response may be confirm 4 weeks later

Length ot the study.

  • Patients in each arm will be treated until progression or toxicity or decision to stop the trial.
  • Responder patient will be treated until 6 cycles. The follow-up assessment will be carried out each 2 months.

Response assessment. According to RECIST criteria.

Resource consumption.

  1. Recording of volumes:

    • All the medication quantities will be recorded in mg. The chemotherapeutic products will be recorded in mg. All the concomitant treatments : RHO, anti-emetics, growth factors, antibiotics or adverse event treatments will be notified.
    • Hospitalizations for treatment and their categories ( inpatient, outpatient, home based treatment) will be noted.
    • All the hospitalizations for adverse events will be recorded (and their category). Grade 1-2 adverse events will be notified in the case report form. Hospitalizations for disease complications or progressions, curative or palliative radiation will be recorded.
  2. Cost calculation :

    • All hospitalisations will be valued by DRGs or day hospitalisation prices, according to the country. Ambulatory care will be valued by appropriate country prices. The drug price will be done by pharmaceutical companies.
  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284778

Contacts
Contact: Alain VERGNENEGRE, MD     05.55.05.66.29.     alain.vergnenegre@unilim.fr    

Locations
France
Service de Pathologie Respiratoire; CHU de Limoges     Recruiting
      Limoges, France, 87000
      Contact: A. Vergnenegre, MD         alain.vergnenegre@unilim.fr    
      Sub-Investigator: F. Bonnaud, MD            
      Principal Investigator: B. Melloni, MD            
      Sub-Investigator: Ch. Decroisette, MD            
      Principal Investigator: A. Vergnenegre, MD            
Service de Pneumologie ; Hôpital saint Antoine, Paris     Recruiting
      Paris, France
      Principal Investigator: C. Chouaid, MD            
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite     Recruiting
      Marseille, France, 13274
      Contact: C. C GIMENEZ, MD     33( 0)4 91 74 47 36     celine.gimenez@mail.ap-hm.fr    
      Sub-Investigator: C. Gimenez, MD            
      Sub-Investigator: F. Barlesi, MD            
Service de Pneumologie; Centre Hospitalier     Recruiting
      Draguignan, France, 83300
      Contact: H. LE CAER, MD     33 (0)4 94 60 51 12     herve.lecaer@ch-draguignan.fr    
      Principal Investigator: H. Lecaer, MD            
Service de Pneumologie; Hôpital de la Croix Rousse     Recruiting
      Lyon, France, 69317
      Contact: M. Perol, MD     33 (0) 4 72 07 17 28     maurice.perol@chu-lyon.fr    
      Principal Investigator: M. Perol, MD            
      Sub-Investigator: D. Arpin, MD            
      Sub-Investigator: E. Biron, MD            
      Sub-Investigator: J.C. Guerin, MD            
Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne     Not yet recruiting
      Toulon Naval, France, 83800
      Contact: H. Berard, MD     33 (0)4 94 09 93 35     hberard@libertysurf.fr    
      Principal Investigator: H Berard, MD            
Service de Pneumologie; Hôpital Bois Guillaume     Recruiting
      Rouen, France, 76233
      Contact: D. Paillotin, MD     33 (0) 2 32 88 90 83     dominique.paillotin@chu-rouen.fr    
      Principal Investigator: D. Paillotin, MD            
      Sub-Investigator: J.F. MUIR, MD            
Clinique Pneumologique; Hôpital Charles Nicolle     Recruiting
      Rouen, France, 76031
      Contact: L. Thiberville, MD     33 (0) 2 32 88 82 47     luc.thiberville@chu-rouen.fr    
      Principal Investigator: L. Thiberville, MD            
      Sub-Investigator: S. Bota, MD            
      Sub-Investigator: G. Nouvet, MD            
Service de Pneumologie-Allergologie; Centre Hospitalier Général     Recruiting
      Perigueux, France, 24019
      Contact: JY. Delhoume, MD     33(0) 5 53 07 71 36     jy.delhoume@ch-perigueux.fr    
      Principal Investigator: JY Delhoume, MD            
Service d’Oncologie Médicale; Clinique Sainte Marguerite     Recruiting
      Toulon, France, 83000
      Contact: JF. Berdah, MD     33 (0)4 94 91 92 22     jf.berdah@wanadoo.fr    
      Principal Investigator: JF. Berdah, MD            
Service de pneumologie; Centre Hospitalier d'Annecy     Recruiting
      Annecy, France, 74011
      Contact: S. Hominal, MD     33 (0) 4-50-88-33-41     hominal.s@free.fr    
      Principal Investigator: H Hominal, MD            
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay     Recruiting
      Mantes La Jolie, France, 78200
      Contact: JB. Auliac, MD     33 (0)1 34 97 40 70     j-b.auliac@ch-mantes-la-jolie.rss.fr    
      Principal Investigator: JB. Auliac, MD            
Service de Pneumologie - Hôpital St Antoine, Paris     Recruiting
      Paris, France, 75571
      Contact: Ch. Chouaid, MD     33 (0)1 49 28 25 12     christos.chouaid@sat.ap-hop-paris.fr    
      Principal Investigator: Ch. Chouaid, MD            
Service de Pneumologie ; Centre hospitalier     Recruiting
      Charleville-Mezieres, France, 08 000
      Contact: S. Chouaibe, MD     33 (0) 3 24 58 73 01     Schouabe@ch-charleville-mezieres.fr    
      Principal Investigator: S. Chouaibe, MD            
Service de Pneumologie, CHU Angers     Recruiting
      Angers, France, 49033
      Contact: Th. Urban, MD     33 (0) 2 41 35 58 44     ThUrban@chu-angers.fr    
      Principal Investigator: Th. Urban, MD            
      Sub-Investigator: Y. le Guen, MD            
Service de Pneumologie; CHG de Roanne     Recruiting
      Roanne, France, 42300
      Contact: V. Grangeon, MD     33 (0)4 77 44 30 64     valérie.grangeon@ch-roanne.fr    
      Principal Investigator: V. Grangeon, MD            
Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris     Recruiting
      Paris, France, 75181
      Contact: N. Roche, MD     33 (0)1 42 34 84 82     roche_nicolas@hotmail.com    
      Principal Investigator: N. Roche, MD            
      Sub-Investigator: F. Giraud, MD            
Service de Pneumologie; Centre Hospitalier     Recruiting
      Beauvais, France, 60 021
      Contact: J. Crequit, MD     33 (0) 3 44 11 22 23     Jacky.crequit@wanadoo.fr    
      Principal Investigator: J. Crequit, MD            
      Sub-Investigator: E. Bouchaert, MD            

Sponsors and Collaborators
University Hospital, Limoges
Groupe Francais De Pneumo-Cancerologie

Investigators
Principal Investigator:     Alain Vergnenegre, MD     CHU Limoges    
Study Chair:     Christos Chouaid, MD     Hôpital Saint Antoine; Paris    
  More Information


Study ID Numbers:   I05026
First Received:   January 31, 2006
Last Updated:   June 27, 2007
ClinicalTrials.gov Identifier:   NCT00284778
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:
lung cancer  
second line treatment  
cost-minimization trial  
Pharmaco-economic study
docetaxel
pemetrexed

Study placed in the following topic categories:
Pemetrexed
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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