Sequential TAS-OX Alternating With TAS-IRI Plus Bevacizumab for Late-Line Metastatic Colorectal Cancer
SCOTI
Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line Metastatic Colorectal Cancer
2 other identifiers
interventional
50
1 country
9
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2023
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2023
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedMarch 18, 2026
March 1, 2026
3 years
March 23, 2023
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease control rate (DCR):
Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD). The disease control rate will be calculated along with 95% confidence interval. As Simon's two stage design is used in the study, 95% CI will be calculated for the two-stage nature of the study design. Response will be determined by independent radiologists using the RECIST criteria.
From baseline until the date of first documented progression of disease, as assessed up to 100 months
Secondary Outcomes (4)
Progression Free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 100 months
Overall Survival (OS)
From date of randomization until the date of death up to 100 months
Overall Response Rate (ORR)
From the date of randomization and measured through the course of study treatment, assessed up to 100 months
Duration of Response
From the date of response until the date of first documented disease progression or death, assessed up to 100 months
Study Arms (1)
Tolerability of TAS-102, oxaliplatin, irinotecan with bevacizumab
EXPERIMENTALEach 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.
- Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.
- Progression of disease must be documented on the most recent scan.
- Presence of measurable disease
- RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).
- Age 18 years or older.
- ECOG performance status 0-1.
- Life expectancy of at least three months.
- Participants with adequate organ function:
- Absolute neutrophil count (ANC) \> 1.5 x 109/L
- Hemoglobin \> 9 g/dL
- Platelets (PLT) \> 70 x 109/L
- AST/ALT \< 5 x ULN
- Albumin within normal limits for institution
- Women who are nursing and discontinue nursing prior to enrollment in the program.
- +3 more criteria
You may not qualify if:
- Participants who have previously received TAS-102.
- Grade 3 or higher peripheral neuropathy (functional impairment).
- Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
- Symptomatic CNS metastases requiring treatment.
- Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).
- Pregnancy or breast feeding.
- Current therapy with other investigational agents.
- Active infection with body temperature \> 38°C due to infection.
- Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration).
- Any anticancer therapy within prior two weeks of first dose of study drug.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.
- Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks.
- Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202, United States
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701, United States
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, 07039, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard S. Hochster, MD
Cancer Institute of New Jersey Rutgers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor of Medicine, Director Clinical Oncology Research
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 10, 2023
Study Start
May 17, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share