Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

Stopped early · Phase 2

Conditions studied: Colorectal Neoplasms, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

In brief

This study, for patients who have Stage IIIC colorectal cancer and who underwent 5-fluorouracil/leucovorin with oxaliplatin (FOLFOX) chemotherapy after surgery, will test to see if regorafenib given after the completion of FOLFOX improves treatment, compared to standard of care (SOC), which is no further treatment.

Key facts

Study ID

NCT02425683

Run by

US Oncology Research

People needed

24

Starts

2015-03-26

Expected to finish

2017-09-21

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A signed Patient Authorization Form (HIPAA) has been obtained prior to registration
• Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
• Age ≥ 18 years.
• Stage IIIC colorectal cancer (T4a, N2a, M0) or (T3-4a, N2b, M0), or (T4b, N1- N2, M0) (per AJCC 7th ed).
• Must have started adjuvant FOLFOX chemotherapy within 8 weeks of resection for colorectal carcinoma
• CT scan that demonstrates no evidence of disease (NED) after completion of adjuvant therapy Note: This CT scan will also be used for Texture analysis.
• Received FOLFOX within 6 weeks before starting regorafenib
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of at least 12 weeks (3 months).
• Complete Metabolic Profile (CMP) within normal limits
• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements:
• Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN
• Alkaline phosphatase limit ≤ 2.5 x ULN
• Lipase ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• International normalized ratio (INR)/ Partial thromboplastin time (PTT) ≤ 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.
• Platelet count ≥ 100,000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.
• Normal carcinoembryonic antigen (CEA) prior to study entry
• Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 according to the Modified Diet in Renal Disease (MDRD) abbreviated formula.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
• Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
• Subject must be able to swallow and retain oral medication.
• Discretionary use of growth factors allowed

You may not qualify if…

• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) v4.03] on repeated measurement) despite optimal medical management.
• Evidence of remaining tumor
• Has local or distant metastasis
• Previous antiangiogenic treatment
• Abnormal hematological, renal, or liver function
• Impaired pulmonary function
• Evidence of ≥ Grade 2 neuropathy
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association (NYHA) > Class II.
• Active coronary artery disease.
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of start of study treatment.
• Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to study entry (ie, signature date of the informed consent form).
• Patients with phaeochromocytoma.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Ongoing infection > Grade 2 NCI-CTCAE v4.03.
• Presence of a non-healing wound, non-healing ulcer, or bone fracture.
• Dehydration Grade ≥ 1 NCI-CTCAE v4.03.
• Patients with seizure disorder requiring medication.
• Persistent proteinuria ≥ Grade 3 NCI-CTCAE v4.03 (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
• Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.

Where it is running

• 24 Sites — Including Dallas, TX, Ocala, FL, Denver, CO, Florida, United States

Full record on ClinicalTrials.gov

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