First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
Colorectal Neoplasms
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged ≥ 18 years
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Suitable to receive mFOLFOX6 regimen as first line metastatic treatment
- At least 1 measurable lesion as per RECIST version 1.1
- Unresectable or unlikely becoming resectable metastatic disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and renal function
Exclusion Criteria:
- Prior systemic anticancer therapy for metastatic colorectal cancer (CRC). Adjuvant chemotherapy for CRC (Stage I, II, III) is permitted, if the adjuvant therapy ended > 6 months before screening and recurrent disease was documented.
- Prior treatment with antivascular endothelial growth factor (anti-VEGF) agents and any signal transduction inhibitors (STIs)
- Uncontrolled hypertension
- Subjects with symptoms, signs, or history of brain metastases
- Any hemorrhage or bleeding event ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks of start of study treatment
- Sensory neuropathy (> CTCAE Grade 1), unresolved toxicity > CTCAE Grade 1 attributed to any prior therapy/procedure excluding alopecia
Sites / Locations
Arms of the Study
Arm 1
Experimental
Regorafenib + oxaliplatin/folinic acid/5-FU (mFOLFOX6)
On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L-folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.