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

Federation Francophone de Cancerologie Digestive16 sites in 1 country43 target enrollmentJanuary 2016

ConditionsColorectal Adenocarcinoma

InterventionsRegorafenib 160 mg

DrugsRegorafenib 160 mg

Overview

Phase: Phase 2
Intervention: Regorafenib 160 mg
Conditions: Colorectal Adenocarcinoma
Sponsor: Federation Francophone de Cancerologie Digestive
Enrollment: 43
Locations: 16
Primary Endpoint: Percentage of Patients With a Tumoral Control Rate at 2 Months
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

September 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Federation Francophone de Cancerologie Digestive

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Metastatic colorectal cancer with histological proof
•Measurable disease according RECIST 1.1
•Age ≥ 70 years
•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

Arms & Interventions

Regorafenib 160 mg

Intervention: Regorafenib 160 mg

Outcomes

Primary Outcomes

Percentage of Patients With a Tumoral Control Rate at 2 Months

Time Frame: 2 months after the start of treatment

Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.