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

Georgetown University

Status and phase

Terminated

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Bevacizumab

Drug: TAS-102

Study type

Interventional

Funder types

Other

Identifiers

NCT02654639

2015-0959

Details and patient eligibility

About

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

Full description

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.