Principal investigator left the institution

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Study Drug:

TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab

Dosing Details:

Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle).

Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.

Inclusion criteria:

• Written informed consent
• Histologically proven, unresectable, evaluable metastatic colorectal cancer
• 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based flourorpyrimidine-containing chemotherapy plus Bevacizumab
• Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy.
• No progressive disease at the time of initiation of maintenance therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
• Adequate organ and marrow function
• Women of child-bearing potential and men must agree to avoid pregnancy
• Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days.

Exclusion Criteria

• Patients whose tumors have progressed on first-line treatment
• Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years.
• Women who are pregnant or lactating
• Unstable heart disease
• Uncontrolled active infection requiring antibiotics within one week prior to first dose.
• Patients with active CNS malignancy.
• Persistent protein in the urine
• Patients with bowel obstruction or uncontrolled vomiting.
• Patients with serious psychiatric or medical conditions that could interfere with treatment.

Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.