25 Participants Needed

Combination Chemotherapy for Colorectal Cancer

CC
Overseen ByCancer Connect
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

Will I have to stop taking my current medications?

The trial requires that you stop using strong inducers or inhibitors of CYP3A4 (a type of enzyme that affects drug metabolism) at least 2 weeks before starting the study treatment.

Is the combination chemotherapy for colorectal cancer safe for humans?

The combination of trifluridine/tipiracil (TAS-102) and bevacizumab has been studied in patients with metastatic colorectal cancer and is generally considered to have controllable safety, though it can cause side effects like nausea and vomiting. These treatments have been evaluated in various studies, showing that while they can be effective, they may also lead to common treatment-related adverse events (unwanted effects).12345

What makes the drug combination of Bevacizumab, Liposomal irinotecan, and TAS102 unique for treating colorectal cancer?

This drug combination is unique because it combines TAS-102 (trifluridine and tipiracil) with bevacizumab, which has shown enhanced activity against colorectal cancer compared to using either drug alone. It is particularly beneficial for patients with metastatic colorectal cancer who have not responded to standard therapies, offering a feasible late-line treatment option that can prolong survival.46789

What data supports the effectiveness of the drug combination for colorectal cancer?

Research shows that the combination of trifluridine/tipiracil and bevacizumab is effective for patients with metastatic colorectal cancer, improving survival rates and showing antitumor activity in various studies.178910

Who Is on the Research Team?

Dustin Deming | Department of Medicine ...

Dustin Deming, M.D.

Principal Investigator

UW Carbone Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic colorectal cancer that's resistant to standard treatments. They must have tried certain chemotherapies and, if applicable, targeted therapies based on their cancer's genetic features. People can't join if they have specific mutations (BRAF V600), high microsatellite instability, or are using strong CYP3A4 affecting drugs.

Inclusion Criteria

My colorectal cancer is confirmed and cannot be removed by surgery.
My cancer is not caused by a mismatch repair deficiency.
I can carry out all my daily activities without help.
See 1 more

Exclusion Criteria

My cancer is not caused by mismatch repair deficiency or high microsatellite instability.
My cancer does not have the BRAF V600 mutation.
I have stopped using certain strong medications 2 weeks before starting therapy.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive liposomal irinotecan, TAS102, and bevacizumab for metastatic colorectal cancer

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Liposomal irinotecan
  • TAS102
Trial Overview The study tests a combination of three drugs: Liposomal Irinotecan, TAS102, and Bevacizumab in patients with advanced colorectal cancer who haven't responded to previous treatments. It aims to see if this mix offers any benefit over existing options.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with Metastatic or Unresectable Colorectal CancerExperimental Treatment3 Interventions

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

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Approved in European Union as Avastin for:
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Approved in United States as Avastin for:
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Approved in Japan as Avastin for:
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Approved in Canada as Avastin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Ipsen

Industry Sponsor

Trials
358
Recruited
74,600+
David Loew profile image

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri profile image

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Published Research Related to This Trial

The maximum tolerated dose (MTD) for the combination of trifluridine/tipiracil (FTD/TPI) and irinotecan was established at FTD/TPI 25 mg/m2 twice daily plus irinotecan 180 mg/m2, with manageable side effects including fatigue and neutropenia.
In a cohort of 24 patients with previously treated metastatic colorectal cancer, the triplet combination of FTD/TPI, irinotecan, and bevacizumab showed promising results, with 12% achieving partial responses and a median progression-free survival of 7.9 months.
Phase I Study of Trifluridine/Tipiracil Plus Irinotecan and Bevacizumab in Advanced Gastrointestinal Tumors.Varghese, AM., Cardin, DB., Hersch, J., et al.[2022]
In a study of 19 patients with metastatic colorectal cancer, the combination of biweekly TAS-102 and bevacizumab resulted in a median progression-free survival of 5.6 months and overall survival of 11.5 months, indicating its efficacy as a third-line treatment.
The treatment was generally safe, with only one patient experiencing severe neutropenia (grade 3 or more), suggesting that this combination therapy may effectively manage cancer while minimizing serious side effects.
Prospective Multicenter Phase II Study of Biweekly TAS-102 and Bevacizumab for Metastatic Colorectal Cancer.Ishizaki, T., Mazaki, J., Enomoto, M., et al.[2021]
In a phase 3 study involving 856 patients with unresectable metastatic colorectal cancer, trifluridine-tipiracil plus bevacizumab showed similar progression-free survival compared to capecitabine plus bevacizumab, with median times of 9.4 months and 9.3 months respectively.
The safety profiles of the two treatments differed significantly, with trifluridine-tipiracil plus bevacizumab leading to higher rates of neutropenia and anemia, while capecitabine plus bevacizumab was associated with more cases of hand-foot syndrome, indicating that both treatments have distinct safety considerations.
Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study.André, T., Falcone, A., Shparyk, Y., et al.[2023]

Citations

Phase I Study of Trifluridine/Tipiracil Plus Irinotecan and Bevacizumab in Advanced Gastrointestinal Tumors. [2022]
Prospective Multicenter Phase II Study of Biweekly TAS-102 and Bevacizumab for Metastatic Colorectal Cancer. [2021]
Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study. [2023]
Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial. [2023]
First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. [2022]
Emetogenicity and Risk Factors of Nausea and Vomiting in Patients With Metastatic Colorectal Cancer Receiving Trifluridine/Tipiracil and Bevacizumab Chemotherapy. [2023]
Metastatic Colorectal Cancer: Management With Trifluridine/Tipiracil . [2017]
TAS-102 plus bevacizumab for patients with metastatic colorectal cancer refractory to standard therapies (C-TASK FORCE): an investigator-initiated, open-label, single-arm, multicentre, phase 1/2 study. [2022]
Trifluridine/tipiracil plus bevacizumab as a first-line treatment for elderly patients with metastatic colorectal cancer (KSCC1602): A multicenter phase II trial. [2021]
[Two Cases of Metastatic Colorectal Cancer Treated with TAS-102 plus Bevacizumab]. [2021]
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