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

Study Overview
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Brief Summary
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Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer

Official Title
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Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

Conditions
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Colorectal Adenocarcinoma

Intervention / Treatment
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* Drug: Regorafenib 160 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regorafenib 160 mg<br> | Drug: Regorafenib 160 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control rate | Number of patients with a complete or partial response or in stability 2 months after the beginning of treatment | 2 months |