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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Bergonié
• Collaborators: Aventis Pharmaceuticals; Novartis; Sanofi-Synthelabo
• Treatments: Fluorouracil; Irinotecan; Leucovorin

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