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

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

Detailed Description
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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.

Official Title
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An Open-Label, Multi-center, Phase 2 Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: TAS-102
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-102 and Bevacizumab<br>Oral TAS-102 and intravenous Bevacizumab. | Drug: TAS-102<br>* TAS-102 Twice a day by mouth day 1-5 and 8-12<br>* Other names: Avastin;Drug: Bevacizumab<br>* Bevacizumab by intravenous infusion once every 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Progression-Free Survival | Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI. | From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Colorectal Cancer, Advanced Colorectal Cancer