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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284778
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : March 29, 2010
Sponsor:
Collaborator:
Groupe Francais De Pneumo-Cancerologie
Information provided by:
University Hospital, Limoges

Brief 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).


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Alimta® Drug: Taxotere® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284778


Locations
Show Show 18 study locations
Sponsors and Collaborators
University Hospital, Limoges
Groupe Francais De Pneumo-Cancerologie
Investigators
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Principal Investigator: Alain Vergnenegre, MD CHU Limoges
Study Chair: Christos Chouaid, MD Hôpital Saint Antoine; Paris
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Responsible Party: Marie SENGELEN, CHU LImoges
ClinicalTrials.gov Identifier: NCT00284778    
Other Study ID Numbers: I05026
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Keywords provided by University Hospital, Limoges:
lung cancer
second line treatment
cost-minimization trial
Pharmaco-economic study
docetaxel
pemetrexed
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action