Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib treatment, as well as to assess treatment continuation of regorafenib.

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

Details

• Lead Sponsor: Clinical Research Support Center Kyush
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Capable of granting informed consent in writing for receiving treatment outlined in this protocol

• The investigators determines that the patient can receive the treatment outlined in this protocol

• Histological diagnosis of adenocarcinoma of either the colon or the rectum, regardless of RAS mutation

• Metastatic colorectal cancer scheduled for treatment with regorafenib

• Lesions are either measurable or non-measurable according to RECIST ver. 1.1

• Contrasted torso CT within 28 days before enrollment

• At least 20 years of age

• PS 0-1

• Bone marrow, hepatic, and renal functions have all been confirmed as normal within 14 days prior to initiation of regorafenib treatment

• Life expectancy of at least 3 months

Exclusion Criteria:

• Used regorafenib previously

• Blood transfusion or granulocyte-colony stimulating factor (G-CSF) administration within 14 days

• Grade 2 or higher fatigue or malaise or asthenia according to NCI-CTCAE ver. 4.0

• History of a different type of cancer according to histological findings or cancer of a different primary focus within the past 5 years. The following are excluded: carcinoma in situ of the cervix, non-melanoma skin cancer, superficial bladder cancer (Ta, Tis, and T1), gastric cancer,non-invasive breast cancer, etc

• Highly invasive surgery, an open biopsy, or who have received significant trauma within 28 days of initiating regorafenib treatment

• Congestive cardiac failure of New York Heart Association (NYHA) >=Class 2

• Unstable angina (symptoms at rest),new-onset angina (onset within past 3 months), or a history of myocardial infarction within 6 months of initiating treatment

• Arrhythmia requiring treatment with anti-arrhythmia drugs

• Uncontrollable hypertension

• Pleural effusion or ascites causing dyspnea (NCI-CTCAE >=Grade 2)

• History of venous or arterial thrombosis or embolism within 6 months prior to initiation of treatment, including cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism

• Patients with active infections of NCI-CTCAE >=Grade 3

• Positive for either hepatitis B (HB)s antigen or hepatitis C virus (HCV) antibody

• Seizure disorders requiring drug treatment

• Cerebral metastases or history of such

• History of organ transplant

• Symptoms or history of hemorrhagic tendency, regardless of severity

• Some form of hemorrhaging (NCI-CTCAE >=Grade 2) within 4 weeks prior to initiating treatment

• Incurable wound, fracture or ulcer

• Renal failure requiring either hemodialysis or peritoneal dialysis

• Dehydration symptoms of NCI-CTCAE >=Grade 1

• Abusing drugs or who are in a physical, psychological, or social state which might impair study participation or evaluation of results

• Interstitial lung disease with active signs or symptoms

• Have difficulty taking oral drugs

• Digestion absorption disorders

• Adverse events resulting from previous treatments or procedures which have not yet resolved (NCI-CTCAE >=Grade 2)

• Received systemic anti-cancer treatments within 2 weeks prior to initiation of regorafenib treatment, including chemotherapy, molecular target drugs, immunotherapy, or hormone therapy

• Poorly controlled glucose tolerance abnormalities due to diabetes mellitus (patients using insulin)

• Active GI ulcers or a history of such

• Glaucoma

• Oral steroids are otherwise contraindicated

• Either pregnant or nursing. Women who may become pregnant must have a negative pregnancy test within 7 days prior to initiating treatment

• Women who may become pregnant, or men whose partners may become pregnant, must agree to use appropriate contraceptives from granting of consent to 3 months after conclusion of regorafenib therapy

• Other illnesses or conditions which, according to the judgment of the investigator, may result in physical harm caused by the study, or which may impair study compliance