Clinical trial NCT00210184: Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Chemotherapy
gastric cancer
geriatric evaluation
efficacy
safety
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Novartis
name: Sanofi-Synthelabo
name: Aventis Pharmaceuticals
First posted: 2005-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 2-month Response Rate
timeFrame: 2 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of inclusion until the date of date of death from any cause, assessed up to 12 months.
measure: Progression-free Survival
timeFrame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Pau
country: France
facility: Centre Hospitalier Universitaire de Pau
city: Perigueux
country: France
facility: Clinique Francheville
city: Villeneuve sur Lot
country: France
facility: Centre Hospitalier Universitaire de Villeneuve sur Lot
Study officials:
affiliation: Institut Bergonié
name: Marianne FONCK, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonck M, Brunet R, Becouarn Y, Legoux JL, Dauba J, Cany L, Smith D, Auby D, Terrebonne E, Traissac L, Mertens C, Soubeyran P, Bellera C, Rainfray M, Mathoulin-Pelissier S. Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric cancer: a first-line phase II study. Clin Res Hepatol Gastroenterol. 2011 Dec;35(12):823-30. doi: 10.1016/j.clinre.2011.08.002. Epub 2011 Sep 8.