Know Cancer

forgot password

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).

Phase 3
18 Years
70 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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.

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

- 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.

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

- Pregnancy or breast feeding.

- Follow-up of the patient impossible.

- Prisoners

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alain Vergnenegre, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Limoges


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

February 2006

Completion Date:

December 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • lung cancer
  • second line treatment
  • cost-minimization trial
  • Pharmaco-economic study
  • docetaxel
  • pemetrexed
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms