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

NCT00210184 | Completed Phase 2 Results

• 2 other identifiers: IB2004-18CEPAFIRI
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Gastric Cancer

Keywords

Chemotherapy; gastric cancer; geriatric evaluation; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  From date of inclusion until the date of date of death from any cause, assessed up to 12 months.

• Progression-free Survival

  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

Study Arms (1)

Irinotecan associated to fluorouracil and leucovorin

EXPERIMENTAL

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

Drug: Irinotecan associated to fluorouracil and leucovorin

Interventions

Irinotecan associated to fluorouracil and leucovorin DRUG

Irinotecan associated to fluorouracil and leucovorin

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead
• Novartis: collaborator
• Sanofi-Synthelabo: collaborator
• Aventis Pharmaceuticals: collaborator

Study Sites (6)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

Location

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Location

Hopital Robert Boulin

Libourne, 33700, France

Location

Centre Hospitalier Universitaire de Pau

Pau, 64000, France

Location

Clinique Francheville

Périgueux, 24000, France

Location

Centre Hospitalier Universitaire de Villeneuve sur Lot

Villeneuve-sur-Lot, 47000, France

Location

Related 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-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.

  PMID: 21907007 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Pr Marianne Fonck
• Organization: Institut Bergonie

+33556333333

Study Officials

• Marianne FONCK, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 21, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: October 6, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-09

Locations

FR (6)