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Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer (CEPAFIRI)

This study has been completed.
Sponsor:
Collaborators:
Novartis
Sanofi-Synthelabo
Aventis Pharmaceuticals
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210184
First received: September 13, 2005
Last updated: December 29, 2011
Last verified: October 2007

September 13, 2005
December 29, 2011
July 2004
Not Provided
Partial response after 2 months of treatment
Same as current
Complete list of historical versions of study NCT00210184 on ClinicalTrials.gov Archive Site
  • Toxicity
  • Geriatric evaluation
  • Survival
Same as current
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Multicentric Phase II Trial: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years Old and More Presenting Gastric Cancer Locally Advanced or Metastatic

The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.

The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: Irinotecan associated to fluorouracil and leucovorin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2009
Not Provided

Inclusion Criteria:

  • 70 years of age or older
  • Gastric cancer, locally advanced or metastatic
  • No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
  • One measurable lesion
  • ECOG < 3
  • Biology and biochemistry within normal limits
  • Life expectancy > 12 weeks

Exclusion Criteria:

  • Other palliative chemotherapy for this cancer
  • Other cancer in the last 5 years
  • Previous treatment with irinotecan
  • Atropine treatment not possible
  • Concomitant cancer therapy except bone radiotherapy
  • Metastases to brain or meninges with symptoms
  • Other severe pathology uncontrolled
  • Problem of compliance
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00210184
IB2004-18, CEPAFIRI
Not Provided
Not Provided
Institut Bergonié
  • Novartis
  • Sanofi-Synthelabo
  • Aventis Pharmaceuticals
Principal Investigator: Marianne FONCK, MD Institut Bergonié
Institut Bergonié
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP