Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer

Part of paid clinical trials in Elizabeth, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05806931
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • TAS-102, oxaliplatin, irinotecan with bevacizumab — DRUG
    Participants will be treated with the study drugs until radiological evidence of disease progression or until treatment discontinuation secondary to adverse events. TAS-OX alternating with TAS-IRI (sequential TASOXIRI) with Bevacizumab, in the treatment of mCRC.

Study Details

This study is to evaluate the disease control rate and time to progression of the sequential combination of oxaliplatin with an alternative anti-metabolite Trifluridine/tipiracil hydrochloride mixture, TAS-102,(TAS-OX) as well as irinotecan in combination with TAS-102 oxaliplatin(TAS-OX) + Bevacizumab in late-line metastatic colorectal cancer (mCRC)

Key Dates

Start date
May 17, 2023
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab
    Each treatment cycle will be fourteen days long. TAS-102 25 mg/m2 will be taken orally twice daily on days 1-5 of each cycle. Oxaliplatin 85 mg/m2 infusion will be given on day one for one cycle alternating with Irinotecan 150 mg/m2 infusion, which will be given on day one the next cycle.

Primary Outcome Measure

Disease control rate (DCR): [ Time Frame: From baseline until the date of first documented progression of disease, as assessed up to 100 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Trinitas Hospital and Comprehensive Cancer CenterElizabethNew Jersey07202
Howard S. Hochster, MD
[email protected]
732-253-5618
RWJBarnabas Health Jersey City Medical CenterJersey CityNew Jersey07302
Howard S. Hochster, MD
[email protected]
732-253-5618
RWJBarnabas Health - Monmouth Medical Center Southern CampusLakewoodNew Jersey08701
Howard S. Hochster, MD
[email protected]
732-253-5618
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)LivingstonNew Jersey07039
Howard S. Hochster, MD
[email protected]
732-253-5618
RWJBarnabas Health - Monmouth Medical CenterLong BranchNew Jersey07740
Howard S. Hochster, MD
[email protected]
732-253-5618
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Howard S. Hochster, MD
[email protected]
732-253-5618
RWJBarnabas Health - Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903
Howard S. Hochster, MD
[email protected]
732-253-5618
RWJBarnabas Health - Robert Wood Johnson University HospitalSomersetNew Jersey08873
Howard S. Hochster
[email protected]
732-253-5618
RWJBarnabas Health - Community Medical CenterToms RiverNew Jersey08755
Howard S. Hochster
[email protected]
732-253-5618

Find similar trials in Elizabeth, NJ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Trinitas Hospital and Comprehensive Cancer Center· Elizabeth, NJRWJBarnabas Health Jersey City Medical Center· Jersey City, NJRWJBarnabas Health - Monmouth Medical Center Southern Campus· Lakewood, NJCooperman Barnabas Medical Center (Saint Barnabas Medical Center)· Livingston, NJRWJBarnabas Health - Monmouth Medical Center· Long Branch, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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