Study on Sequential TAS-OX and TAS-IRI with Bevacizumab for Advanced Metastatic Colorectal Cancer

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05806931

Provider View

This clinical trial is testing a new treatment approach for patients with advanced metastatic colorectal cancer. The study evaluates the effectiveness of alternating chemotherapy drugs TAS-OX and TAS-IRI, combined with Bevacizumab, to control the disease and delay its progression.

Patient Parameters

Program Overview

The purpose of this study is to see if a new combination of chemotherapy drugs, TAS-OX and TAS-IRI, along with Bevacizumab, can help control advanced metastatic colorectal cancer. The study will assess how well this treatment works in managing the disease and delaying its progression. Participants will continue receiving the treatment until their cancer progresses or they experience side effects that require stopping the treatment.

Description

This phase II clinical trial is exploring the effectiveness of a new treatment regimen for patients with advanced metastatic colorectal cancer (mCRC). The treatment involves alternating between two chemotherapy combinations: TAS-OX (which includes oxaliplatin and TAS-102) and TAS-IRI (which includes irinotecan and TAS-102), along with the drug Bevacizumab. The goal is to determine if this approach can better control the cancer and delay its progression. Participants will receive the treatment until their cancer shows signs of progression on scans or they experience side effects that require stopping the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV colorectal cancer that has worsened after standard treatments, including 5-FU, irinotecan, oxaliplatin, and appropriate antibody therapy.
  • Have received antibody therapy with Bevacizumab and an anti-EGFR antibody if RAS wild type, unless medically unable to do so.
  • Allowed to participate if unable to tolerate standard treatments due to reversible side effects.
  • If cancer returned during or within six months after adjuvant chemotherapy, this counts as one treatment for advanced disease.
  • Cancer progression must be confirmed on the latest scan.
  • Must have measurable cancer.
  • RAS mutation and MMR status must be known or tissue available for testing.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Life expectancy of at least three months.
  • Adequate organ function, including:
    • Neutrophil count > 1.5 x 10^9/L
    • Hemoglobin > 9 g/dL
    • Platelets > 70 x 10^9/L
    • Liver enzymes (AST/ALT) < 5 times the upper limit of normal
    • Normal albumin levels
  • Women must stop nursing before joining the study.
  • Able to take oral medication.
  • Willing to follow study procedures and sign informed consent.

Exclusion Criteria

  • Have previously received TAS-102.
  • Severe nerve damage (Grade 3 or higher).
  • Unable to tolerate irinotecan due to uncontrolled diarrhea.
  • No specific exclusions for Bevacizumab unless contraindicated by the doctor.
  • Active brain metastases needing treatment.
  • Other active cancers within the last three years, except for certain skin or non-invasive cancers.
  • Pregnant or breastfeeding.
  • Currently on other experimental treatments.
  • Active infection with fever over 38°C.
  • Major surgery within the last four weeks (surgical wounds must be healed).
  • Any cancer treatment within two weeks before starting the study drug.
  • Allergic reactions to similar drugs as TAS-102.
  • Currently in another clinical study or received experimental treatment within the last four weeks.
  • Severe allergic reactions to oxaliplatin or irinotecan, or mild reactions not controlled with medication.
  • Unresolved side effects from previous treatments, except for certain conditions like anemia or hair loss.

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