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).
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
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.
- 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
- Brain scan, bone scintigraphy and/or bone x ray (within 28 days)
- Bronchial endoscopy (within 28 days)
- EKG, echocardiography according to history
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
- 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.
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
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Alain Vergnenegre, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)