Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Georgetown University
• Treatments: Bevacizumab; Trifluridine

Criteria

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.