TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study

Summary

This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.

Conditions

• Advanced Colorectal Carcinoma
• Metastatic Colon Adenocarcinoma
• Metastatic Rectal Adenocarcinoma
• Recurrent Colon Adenocarcinoma
• Recurrent Colorectal Adenocarcinoma
• Recurrent Rectal Adenocarcinoma
• Stage III Colon Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8
• Stage IIIA Colon Cancer AJCC v8
• Stage IIIA Colorectal Cancer AJCC v8
• Stage IIIB Colorectal Cancer AJCC v8
• Stage IIIB Rectal Cancer AJCC v8
• Stage IIIC Colon Cancer AJCC v8
• Stage IIIC Colorectal Cancer AJCC v8
• Stage IV Colon Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVA Rectal Cancer AJCC v8
• Stage IVB Colon Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVB Rectal Cancer AJCC v8
• Stage IVC Colon Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8
• Stage IVC Rectal Cancer AJCC v8
• Unresectable Colon Adenocarcinoma
• Unresectable Colorectal Carcinoma
• Unresectable Rectal Adenocarcinoma

Interventions

DRUG

Irinotecan

Given IV

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Trifluridine and Tipiracil Hydrochloride

Given PO

Sponsors & Collaborators

• National Comprehensive Cancer Network

  collaborator NETWORK

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Christos Fountzilas, MD · Roswell Park Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-27

Primary Completion

2024-09-05

Completion

2024-09-05

FDA Drug

Yes

Countries

• United States

Study Locations