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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04109924
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Colorectal Carcinoma
  • Metastatic Colon Adenocarcinoma
  • Metastatic Rectal Adenocarcinoma
  • Recurrent Colon Adenocarcinoma
  • Recurrent Colorectal Adenocarcinoma
  • Recurrent Rectal Adenocarcinoma
  • Stage III Colon Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IIIA Colon Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IV Colon Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVA Rectal Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVB Rectal Cancer AJCC v8
  • Stage IVC Colon Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8
  • Stage IVC Rectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Unresectable Colorectal Carcinoma
  • Unresectable Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Trifluridine and Tipiracil Hydrochloride — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 27, 2019
Status verified
Nov 2025
Primary completion
Sep 5, 2024
Completion
Sep 5, 2024

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan, bevacizumab, TAS-102)
    Patients receive irinotecan IV over 90 minutes and bevacizumab IV over 10 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride PO BID on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Median Progression Free Survival (PFS) [ Time Frame: Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Roswell Park Cancer InstituteBuffaloNew York14263-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLRutgers Cancer Institute of New Jersey· New Brunswick, NJRoswell Park Cancer Institute· Buffalo, NYFox Chase Cancer Center· Philadelphia, PA

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