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

Gastric Cancer Clinical Trial

— CEPAFIRI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210184
• Other study ID #: IB2004-18
• Secondary ID: CEPAFIRI
• Status: Completed
• Phase: Phase 2
• Start date: July 21, 2004
• Est. completion date: April 2010

Study information

• Verified date: September 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan associated to fluorouracil and leucovorin

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest	Bordeaux
France	Hopital Robert Boulin	Libourne
France	Centre Hospitalier Universitaire de Pau	Pau
France	Clinique Francheville	Perigueux
France	Centre Hospitalier Universitaire de Villeneuve sur Lot	Villeneuve sur Lot

Sponsors (4)

Lead Sponsor	Collaborator
Institut Bergonié	Aventis Pharmaceuticals, Novartis, Sanofi-Synthelabo

Country where clinical trial is conducted

France, 

References & Publications (1)

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-Pélissier S. Evaluation of efficacy and safety of FOLFIRI for elderly patients with gastric canc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-month Response Rate	Response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.; Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).	2 months
Secondary	Overall Survival	OS was defined as the time from trial inclusion to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.	From date of inclusion until the date of date of death from any cause, assessed up to 12 months.
Secondary	Progression-free Survival	PFS was defined as time since trial inclusion to progression or death from any cause, whichever occurred first, and data from patients progression-free and lost to follow-up before the study end were censored at date of last news. The PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	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