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

Federation Francophone de Cancerologie Digestive

Status and phase: Completed; Phase 2

Conditions: Colorectal Adenocarcinoma

Treatments: Drug: Regorafenib 160 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02788006

FFCD 1404 - REGOLD

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Regorafenib 160 mg

Experimental group

Treatment:

Drug: Regorafenib 160 mg