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Clinical Trial 20489

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04109924

Phase: Phase II
Prinicipal Investigator: Iman Imanirad

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Overview

Study Title

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

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.

Objective

Determine the median progression free survival (PFS) benefit of FOLFIRI naïve patients treated with TAS-102 + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile

Treatments

Therapies

Medications

Avastin (Bevacizumab); Bevacizumab (); CPT-11 (irinotecan); Camptosar (irinotecan); TAS 102 (); irinotecan ()

Inclusion Criteria

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
  • Adequate organ function as outlined per protocol
  • 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
  • Other criteria may apply

  • Exclusion 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 => 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
  • Other criteria may apply

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