Clinical Trials /

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

NCT04294264

Description:

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.

Related Conditions:
  • Colon Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
  • Official Title: TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 071801
  • SECONDARY ID: NCI-2020-00871
  • SECONDARY ID: Pro2018001469
  • SECONDARY ID: 071801
  • SECONDARY ID: P30CA072720
  • NCT ID: NCT04294264

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

Interventions

DrugSynonymsArms
Oxaliplatin1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669Treatment (TAS-102, oxaliplatin)
Trifluridine and Tipiracil HydrochlorideLonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine, Trifluridine/Tipiracil, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102Treatment (TAS-102, oxaliplatin)

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVE:

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (TAS-102, oxaliplatin)ExperimentalPatients 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
  • Trifluridine and Tipiracil Hydrochloride

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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:

          -  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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:Up to 2 years
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression free survival
Time Frame: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
Safety Issue:
Description:Progression will be assessed by a computed tomography CT scan according to RECIST criteria version 1.1. This criterion will be estimated by the Kaplan-Meier method. Patients who have not progressed or died at the time of analysis will be censored at the time of their latest follow-up with clinically stable disease.
Measure:Overall survival
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Disease control rate
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:Up to 2 years
Safety Issue:
Description:Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
Measure:Incidence of adverse events
Time Frame:Up to 28 days post treatment
Safety Issue:
Description:All recorded adverse events will be listed and tabulated by system organ class and dose level. Will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 5.0 for toxicity and adverse event reporting.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Rutgers, The State University of New Jersey

Last Updated

March 2, 2020