TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma

May 24, 2023 updated by: Farshid Dayyani, University of California, Irvine

A Phase Ib Multicenter Study of TAS-102 in Combination With Irinotecan in Patients With Advanced Recurrent or Unresectable Gastric and Gastroesophageal Adenocarcinoma After at Least One Line of Treatment With a Fluoropyrimidine and Platinum Containing Regimen

This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment on study will be administered in 14 day cycles.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
  • Must have locally advanced, recurrent, or metastatic disease not amenable to curative intent surgery.
  • Must have progressed, or not tolerated, at least one line of treatment with a platinum and/or fluoropyrimidine containing regimen. At least one cycle of combination chemotherapy including a platinum (oxaliplatin, cisplatin, carboplatin) and/or fluoropyrimidine (capecitabine or 5-Fluorouracil) based regimen for advanced disease. Combination regimens with platinum/fluoropyrimidine containing a taxane and or a checkpoint inhibitor are allowed. Patients progressing within six months of perioperative chemotherapy or definitive chemoradiation for localized disease are eligible. Patients who have exhausted all other standard of care options are also eligible.
  • Age ≥ 18 years
  • Performance status: ECOG performance status ≤2
  • Life expectancy of greater than 3 months

  • Adequate organ and marrow function as defined below:

    1. leukocytes : ≥ 3,000/mcL
    2. absolute neutrophil count: ≥ 1,500/mcL
    3. platelets: ≥ 80,000/mcl
    4. total bilirubin: within normal institutional limits
    5. AST(SGOT)/ALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present
    6. creatinine: < 1.5 X upper limit of normal

  • The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

    1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

    1. Has not undergone a hysterectomy or bilateral oophorectomy; or
    2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Ability to swallow tablets
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1.
  • All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases due to poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Prior treatment with irinotecan or TAS-102
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.
  • Inability to comply with study and follow-up procedures as judged by the Investigator
  • Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAS-102 and Irinotecan
Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days.
Drug: Irinotecan
Given IV
Other Names:
  • CPT-11
  • CAMPTOSAR
Drug: TAS-102
Given PO
Other Names:
  • LONSURF
  • trifluoridine and tipiracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Progression-free Survival at 6 Months
Time Frame: 6 Months
This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Grade 3-5 Adverse Events
Time Frame: 8 Weeks
To evaluate the tolerability of administering TAS-102 in combination with Irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma for the first 2 cycles of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
8 Weeks
Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan
Time Frame: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
To assess the objective response rate to the combination of TAS-102 and Irinotecan. Objective response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan
Time Frame: From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.
To evaluate overall survival in patients with advanced recurrent or unresectable and gastroesophageal adenocarcinoma treated with this combination of TAS-102 and Irinotecan.
From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Farshid Dayyani, MD, PhD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

July 21, 2022

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCI 18-125 [HS# 2019-5179]
  • 2019-5179 (Other Identifier: University of California, Irvine)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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