Pharmaco-economic Study of a Second Line Treatment in Advanced Non Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

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).
    

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.
    

Intervention name(s): Alimta®; Taxotere®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; second line treatment; cost-minimization trial; Pharmaco-economic study; docetaxel; pemetrexed