TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
NCT ID: NCT04294264
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2019-02-12
2026-03-27
Brief Summary
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Detailed Description
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I. Overall response rate (ORR).
SECONDARY OBJECTIVES:
I. Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability.
OUTLINE:
Patients receive trifluridine and tipiracil hydrochloride (TAS-102) orally (PO) twice daily (BID) on days 1-5 and oxaliplatin intravenously (IV) over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (TAS-102, oxaliplatin)
Patients receive TAS-102 PO BID on days 1-5 and oxaliplatin IV over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Oxaliplatin
Given IV
Trifluridine and Tipiracil Hydrochloride
Given PO
Interventions
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Oxaliplatin
Given IV
Trifluridine and Tipiracil Hydrochloride
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who had received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen
* Progression of disease must be documented on the most recent scan
* Presence of measurable disease
* RAS mutation and mismatch repair deficiency (MMR) status must be determined (or tissue availability for testing if not already determined)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy of at least 3 months
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Hemoglobin \>= 9 g/dL
* Platelets (PLT) \>= 75 x 10\^9/L
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 5 x upper limit of normal (ULN)
* Adequate contraception if applicable
* Women who are nursing and discontinue nursing prior to enrollment in the program
* Ability to take oral medication (i.e., no feeding tube)
* Patient able and willing to comply with study procedures as per protocol
* Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures
Exclusion Criteria
* Grade 2 or higher peripheral neuropathy (functional impairment)
* Symptomatic central nervous system (CNS) metastases requiring treatment
* Other active malignancy within the last 3 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 degree Celsius (C) due to infection
* Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to drug administration)
* Any anticancer therapy within prior 3 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 4 weeks
* Grade 3 or higher hypersensitivity reaction to oxaliplatin, 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Howard S. Hochster, MD
Associate Director for Clinical Research Medical Oncology
Principal Investigators
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Howard S Hochster
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2020-00871
Identifier Type: REGISTRY
Identifier Source: secondary_id
Pro2018001469
Identifier Type: -
Identifier Source: secondary_id
071801
Identifier Type: OTHER
Identifier Source: secondary_id
Pro2018001469
Identifier Type: -
Identifier Source: org_study_id
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