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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2022
  • participants needed
    40
  • sponsor
    Roswell Park Cancer Institute
Updated on 27 April 2021

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.

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.

Details
Condition Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Colon Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Colon Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8, Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma, Advanced Colorectal Carcinoma, Recurrent Colon Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Recurrent Rectal Adenocarcinoma, Unresectable Colorectal Carcinoma
Treatment bevacizumab, Irinotecan, Trifluridine and Tipiracil Hydrochloride
Clinical Study IdentifierNCT04109924
SponsorRoswell Park Cancer Institute
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage IVA Colorectal Cancer AJCC v8 or Recurrent Colon Adenocarcinoma or Stage III Colorectal Cancer AJCC v8 or Stage III Colon Cancer AJCC v8 or Recu...?
Do you have any of these conditions: Unresectable Colorectal Carcinoma or Stage IVC Rectal Cancer AJCC v8 or Stage IV Colon Cancer AJCC v8 or Recurrent Rectal Adenocarcinoma or Stage III ...?
Do you have any of these conditions: Stage IIIA Colon Cancer AJCC v8 or Stage IVA Rectal Cancer AJCC v8 or Stage III Colorectal Cancer AJCC v8 or Stage IVA Colorectal Cancer AJCC v8 or St...?
Do you have any of these conditions: Stage IIIB Rectal Cancer AJCC v8 or Recurrent Colon Adenocarcinoma or Recurrent Rectal Adenocarcinoma or Stage III Rectal Cancer AJCC v8 or Metastatic...?
Do you have any of these conditions: Stage IIIB Rectal Cancer AJCC v8 or Unresectable Rectal Adenocarcinoma or Stage IVB Colorectal Cancer AJCC v8 or Stage IIIB Colorectal Cancer AJCC v8 ...?
Do you have any of these conditions: Advanced Colorectal Carcinoma or Stage III Colorectal Cancer AJCC v8 or Stage IIIC Colorectal Cancer AJCC v8 or Stage III Rectal Cancer AJCC v8 or Sta...?
Do you have any of these conditions: Stage IVB Colorectal Cancer AJCC v8 or Stage IVA Colorectal Cancer AJCC v8 or Stage III Rectal Cancer AJCC v8 or Stage IIIA Colorectal Cancer AJCC v8 ...?
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 >= 1000/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 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
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
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