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
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: Irinotecan associated to fluorouracil and leucovorin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Partial response after 2 months of treatment

Secondary Outcome Measures:
  • Toxicity
  • Geriatric evaluation
  • Survival

Estimated Enrollment: 43
Study Start Date: July 2004
Estimated Study Completion Date: July 2009
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210184

Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Hopital Robert Boulin
Libourne, France, 33700
Centre Hospitalier Universitaire de Pau
Pau, France, 64000
Clinique Francheville
Perigueux, France, 24000
Centre Hospitalier Universitaire de Villeneuve sur Lot
Villeneuve sur Lot, France, 47000
Sponsors and Collaborators
Institut Bergonié
Novartis
Sanofi-Synthelabo
Aventis Pharmaceuticals
Investigators
Principal Investigator: Marianne FONCK, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210184     History of Changes
Other Study ID Numbers: IB2004-18, CEPAFIRI
Study First Received: September 13, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Chemotherapy
gastric cancer
geriatric evaluation
efficacy
safety

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014