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

COMPLETEDPHASE2

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

A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pre-Treated Metastatic Colorectal Cancer (TABAsCO)

NCT04109924•Roswell Park Cancer Institute

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVE: I. Determine the median progression free survival (PFS) benefit of leucovorin calcium, 5-fluorouracil, and irinotecan (FOLFIRI) naive patients treated with trifluridine and tipiracil hydrochloride (TAS-102) + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. SECONDARY OBJECTIVE: I. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile. OUTLINE: Patients receive irinotecan intravenously (IV) over 90 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Advanced colorectal cancer (metastatic or unresectable): Histologically or cytological proven adenocarcinoma of the colon or rectum which is metastatic or otherwise incurable
•Prior treatment with a fluoropyrimidine (5-fluorouracil \[5-FU\] or capecitabine) and oxaliplatin in the metastatic/unresectable setting OR, recurrence within 12 months of adjuvant therapy with a regimen that included oxaliplatin
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Hemoglobin \>= 9 g/dL
•Absolute neutrophil count \>= 1500/mm\^3
•Platelet count \>= 100,000/mm\^3
•Creatinine \< 1.5 upper limit of normal (ULN) or if \>= 1.5 x ULN creatinine clearance (CRCL) \>= 30 mL/min (by Cockcroft-Gault)
•Bilirubin \< 1.5 x ULN
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN or =\< 5 x ULN if with hepatic metastases
•Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
+2 more criteria

Exclusion Criteria

•Prior treatment with TAS-102 or irinotecan
•Anti-cancer therapy within 2 weeks of the planned first dose of study medication
•Unresolved toxicities from prior therapy of \> grade 1, excluding alopecia or similar toxicities which are not deemed to be clinically significant or put the participant at greater risk. Grade 2 neuropathy is permitted
•Major surgery within 4 weeks of anticipated start of therapy
•Uncontrolled hypertension: systolic blood pressure \>= 150, diastolic blood pressure \>= 100
•Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
•Arterial or venous thrombotic or embolic events within 3 months of study initiation, unless well controlled on stable anti-coagulation for \>= 2 weeks. This excludes uncomplicated catheter associated venous thrombosis
•History of cerebrovascular or myocardial ischemia within 6 months of initiation
•National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade 3 or greater hemorrhage within the past 4 weeks
•Proteinuria \>= 2+, unless 24 hour urine collection demonstrates =\< 1 g of protein OR spot protein: creatinine demonstrates a ratio of =\< 1
+7 more criteria

Locations (4)

Moffitt Cancer Center

Tampa, Florida, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 27, 2019

Primary Completion Date

September 5, 2024

Completion Date

September 5, 2024

Last Updated

February 10, 2026

Enrollment

ACTUAL participants

Conditions

Advanced Colorectal CarcinomaMetastatic Colon AdenocarcinomaMetastatic Rectal AdenocarcinomaRecurrent Colon AdenocarcinomaRecurrent Colorectal AdenocarcinomaRecurrent Rectal AdenocarcinomaStage III Colon Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Colon Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Colon Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colon Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Rectal Cancer AJCC v8Stage IVB Colon Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Rectal Cancer AJCC v8Stage IVC Colon Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8Stage IVC Rectal Cancer AJCC v8Unresectable Colon AdenocarcinomaUnresectable Colorectal CarcinomaUnresectable Rectal Adenocarcinoma

Interventions

Irinotecan

DRUG

Bevacizumab

BIOLOGICAL

Trifluridine and Tipiracil Hydrochloride

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

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Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer