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Trial record 2 of 87 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

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

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ClinicalTrials.gov Identifier: NCT04294264
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Howard S. Hochster, MD, Rutgers Cancer Institute of New Jersey

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.

Condition or disease Intervention/treatment Phase
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 Drug: Oxaliplatin Drug: Trifluridine and Tipiracil Hydrochloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Ai Heng
  • Aiheng
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669

Drug: Trifluridine and Tipiracil Hydrochloride
Given PO
Other Names:
  • Lonsurf
  • TAS 102
  • TAS-102
  • Tipiracil Hydrochloride Mixture with Trifluridine
  • Trifluridine/Tipiracil
  • Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 2 years ]
    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 :
  1. 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 ]
    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.

  2. Overall survival [ Time Frame: Up to 2 years ]
  3. Disease control rate [ Time Frame: Up to 2 years ]
  4. Duration of response [ Time Frame: Up to 2 years ]
    Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.

  5. Incidence of adverse events [ Time Frame: Up to 28 days post treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294264


Locations
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United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Delia Radovich    973-322-5200    delia.radovich@rwjbh.org   
Principal Investigator: Delia Radovich         
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Howard S. Hochster    732-253-5618    howard.hochster@rutgers.edu   
Principal Investigator: Howard S. Hochster         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Howard S Hochster Rutgers Cancer Institute of New Jersey
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Responsible Party: Howard S. Hochster, MD, Associate Director for Clinical Research Medical Oncology, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT04294264    
Other Study ID Numbers: 071801
NCI-2020-00871 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro2018001469
071801 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Trifluridine
Oxaliplatin
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents