Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer

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

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Criteria

Inclusion Criteria:

• Metastatic colorectal cancer with histological proof

• Measurable disease according RECIST 1.1

• Age ≥ 70 years

• ECOG ≤ 1

• Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min

• Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities

• Geriatric Questionnaires answered

• Life-expectancy ≥ 3 months

• Informed Consent Signed

Exclusion Criteria:

• Not able to swallow tablets (crushed tablets are not allowed)

• Previous treatment with regorafenib or other multikinase treatment

• Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated

• Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion

• Toxicity > grade 1 not resolved with previous treatment

• Major surgery in the 28 days before the inclusion

• Non cicatrized injury, ulcer or bone fracture

• Congestive Cardiac insufficiency classe >2 (NYHA)

• Unstable angor in the last 3 months

• Myocardial Infraction in the 6 months before inclusion

• HTA not controlled

• Pheochromocytome

• Arterial or venous thromboembolism in the past 6 months

• Infection of grade > 2

• VIH infection

• B or C hepatitis necessiting a specific treatment

• Cirrhosis

• Suspicion of brain metastasis or brain metastasis

• Haemorraghe ofgrade >3 in the last weeks

• Symptomatic Pulmonary fibrosis

• Proteinuria > grade 3

• Malabsorption

• Allergy know to the treatment or to one similar treatment or to one treatment component

• Systemic anti-cancer drug during the study or the the last 4 weeks

• Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor

• Social, psychological or medical condition which can interfere with the study participation