Status:
COMPLETED
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Advanced Colorectal Carcinoma
Metastatic Colon Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 canno...
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 tipirac...
Eligibility Criteria
Inclusion
- 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
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
- 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
- Untreated brain metastases
- History of abnormal glucuronidation of bilirubin (Gilbert's syndrome)
- History of second primary malignancy within 3 years prior to enrollment, excluding in-situ cervical carcinoma, non-melanoma skin cancer or malignancy of equivalent risk which is highly unlikely to require systemic treatment in the next 2 years
- Have known active infection which would heighten the risk of complications
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04109924
Start Date
December 27 2019
End Date
September 5 2024
Last Update
August 11 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
3
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
4
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111