TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

NCT04294264 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: Pro2018001469NCI-2020-00871071801P30CA072720
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, 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.

Conditions

Metastatic Colorectal Carcinoma; Recurrent Colon Carcinoma; Refractory Colorectal Carcinoma; Stage IV Colon Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.

  Up to 2 years

Secondary Outcomes (5)

• Progression free survival

  From the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years

• Overall survival

  Up to 2 years

• Disease control rate

  Up to 2 years

• Duration of response

  Up to 2 years

• Incidence of adverse events

  Up to 28 days post treatment

Study Arms (1)

Treatment (TAS-102, oxaliplatin)

EXPERIMENTAL

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.

Drug: Oxaliplatin; Drug: Trifluridine and Tipiracil Hydrochloride

Interventions

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (TAS-102, oxaliplatin)

Trifluridine and Tipiracil Hydrochloride DRUG

Given PO

Also known as: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine, Trifluridine/Tipiracil, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Treatment (TAS-102, oxaliplatin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed stage IV colon cancer (American Joint Committee on Cancer \[AJCC\] 7th edition) that has progressed after standard therapy that included fluorouracil (5-FU), irinotecan, oxaliplatin, bevacizumab (unless contraindicated) and an anti-EGFR antibody, if RAS wild type. Patients who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate
• 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

You may not qualify if:

• Patients who have previously received TAS-102
• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

Location

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Oxaliplatin; Trifluridine; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Howard S Hochster

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

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: Associate Director for Clinical Research Medical Oncology

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: February 12, 2019
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)