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

This study has been completed.
Sponsor:
Collaborator:
Groupe Francais De Pneumo-Cancerologie
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00284778
First received: January 31, 2006
Last updated: March 26, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Estimated Enrollment: 150
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
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: NCT00284778

Locations
France
Service de Pneumologie, CHU Angers
Angers, France, 49033
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, France, 74011
Service de Pneumologie; Centre Hospitalier
Beauvais, France, 60 021
Service de Pneumologie ; Centre hospitalier
Charleville-Mezieres, France, 08 000
Service de Pneumologie; Centre Hospitalier
Draguignan, France, 83300
Service de Pathologie Respiratoire; CHU de Limoges
Limoges, France, 87000
Service de Pneumologie; Hôpital de la Croix Rousse
Lyon, France, 69317
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes La Jolie, France, 78200
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, France, 13274
Service de Pneumologie ; Hôpital saint Antoine, Paris
Paris, France
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, France, 75571
Service de Pneumologie et Réanimation ; Hôpital Hôtel Dieu - Paris
Paris, France, 75181
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Perigueux, France, 24019
Service de Pneumologie; CHG de Roanne
Roanne, France, 42300
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, France, 76031
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, France, 76233
Service d'Oncologie Médicale; Clinique Sainte Marguerite
Toulon, France, 83000
Service de Pathologie Respiratoire; Hôpital d'Instruction des Armées Sainte-Anne
Toulon Naval, France, 83800
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

No publications provided

Responsible Party: Marie SENGELEN, CHU LImoges
ClinicalTrials.gov Identifier: NCT00284778     History of Changes
Other Study ID Numbers: I05026
Study First Received: January 31, 2006
Last Updated: March 26, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 28, 2014