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

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Irinotecan associated to fluorouracil and leucovorin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00210184

IB2004-18

CEPAFIRI

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 70 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Irinotecan associated to fluorouracil and leucovorin

Experimental group

Description:

On D1, as a single 90-minute intravenous infusion diluted in 250 ml of saline (sodium chloride a 9 ‰), or isotonic glucose, at a dose of 180 mg/m2. Dosage adjustments are provided in case of severe toxicity. Then 5FU/ folinic acid: 400 mg/m2 of 5-FU as an IV bolus followed by a continuous 2400 mg/m2 infusion over 46 hours with 400 mg/m2 of folinic acid or 200 mg/m2 of l-folinic acid as a 2-hour infusion before 5-FU administration. Doses of 5-FU are adjusted according to clinical tolerance. Resume on D15 for 6 months

Treatment:

Drug: Irinotecan associated to fluorouracil and leucovorin