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Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer


Inclusion Criteria:



- Non-small cell bronchopulmonary cancer established by histological and/or
cytological methods;

- Advanced or metastatic disease (stage IIIB or IV);

- At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by
CT scan) outside of the irradiated area;

- No prior chemotherapy;

- Previous radiotherapy permitted as long as there has been a washout period of at
least 4 weeks;

- Age >= 18 years old;

- ECOG Performance Status (PS): 0-1;

- Life expectancy >3 months;

- Hepatic and renal functions and blood count satisfactory:

- Blood counts: white blood cells >= 3.0 x 10^9/l, neutrophils >= 1.5 x 10^9/l,
platelets >= 150 x 10^9/l, haemoglobin >= 9 g/dl,

- Hepatic function: bilirubin within the limit of the normal upper value,
aspartate transaminases (AST) or alanine transaminases (ALT) <= 2.5 times the
normal upper value

- Renal function: creatinine clearance (calculated according to Cockroft and
Gault) >= 40 ml/min;

- Patients of reproductive age must use an effective contraceptive method;

- Informed consent form signed before any procedure undertaken connected with the study

Exclusion Criteria:

- Pregnant or breastfeeding patient;

- Past record of other cancers (excluding basocellular or epidermoid cutaneous
carcinoma or cured carcinoma of the cervix);

- Symptomatic cerebral or leptomeningeal metastases;

- Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);

- Presence of a serious disease or medical condition incompatible with the study (at
the discretion of the investigator);

- Treatment with another test product or participation in another therapeutic trial in
the 4 weeks preceding inclusion in the study;

- Concomitant treatment by any other anticancer therapy;

- Concomitant treatment with phenytoin.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.

Principal Investigator

Marie SEBILLE, Dr

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

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

Study ID:

L_8907

NCT ID:

NCT00271271

Start Date:

June 2003

Completion Date:

October 2006

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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