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Gastroesophageal Junction AdenocarcinomaPhase 2NCT04808791

iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 2 study testing Irinotecan, Oxaliplatin and TAS 102 (Trifluridine/Tipiracil) in people with Gastroesophageal Junction Adenocarcinoma and Advanced Gastric Carcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and feasibility of Irinotecan, Trifluridine/Tipiracil (TAS-102) and Oxaliplatin (iTTo) for treatment naïve advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Irinotecan, Oxaliplatin and TAS 102 (Trifluridine/Tipiracil)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteCanada
Study dates
27 Oct 2021to 21 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be 18 years of age or older.
  • Histologically documented locally advanced or metastatic gastric or GEJ adenocarcinoma not previously treated with palliative systemic therapy.
  • Patients must be capable of providing consent to enrolment and treatment.
  • Patients with a performance status of ECOG 0-1 will be eligible for enrolment (see appendix 1).
  • Measurable disease must be present according to RECIST criteria V1.1 (see appendix ).
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
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  • Patients (men and women) of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
  • Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug.
  • Male patients should agree to not donate sperm during the study and for a period of at least 6 months after last dose of study drug.
  • Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Patients may have received prior surgery if this surgery was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
  • Patients who have treated brain metastasis (via local radiation standards or surgical resection or local ablative techniques) and who are either off steroids or on a stable dose of steroids for at least one month (30 days), AND who are off anticonvulsants, AND have radiological documented stability of lesions for at least 3 months may be eligible. Each case should be discussed with the study Chair.
  • Patients who have received prior chemotherapy or radiation delivered as part of initial curative therapy (i.e. neoadjuvant or adjuvant chemotherapy administered alone and/or concurrently delivered with radiation and/or surgery) are permitted as long as that treatment was completed at least 6 months prior to study start date.
  • Patients may have received prior palliative radiotherapy (unless radiation was curative therapy to pelvis or to ≥ 25% of bone marrow stores) if this radiation was ≥ 4 weeks before study entry and patients must have recovered from the toxic effects of this treatment.
  • Patients with unknown Her2/neu status, or negative Her2/neu status based on IHC and/or FISH/CISH (Testing does not need to be done unless it is standard of care at participating centres).
  • The following adequate organ function laboratory values must be met:
  • Hematological:
  • Absolute neutrophil count (ANC) >1.5 x10^9/L Platelet count >100 x10^9/L Hemoglobin >8 g/dL (may have been transfused)
  • Renal:
  • serum creatinine ≤ upper limit of institutional normal OR calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula (or local institutional standard method)
  • Hepatic:
  • Total serum bilirubin <1.5x ULN AST and ALT <2.5x ULN (or ≤ 5 x ULN for patients with documented metastatic disease to the liver)

Who cannot join

  • Patients who have received prior palliative chemotherapy for their advanced gastric or GEJ tumor.
  • Prior curative or palliative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores.
  • History of bowel obstruction due to peritoneal metastases or clinically documented ascites requiring paracenteses.
  • Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or uterus or non-melanoma skin cancer or in-situ carcinoma of the prostate (Gleason score ≤ 7, with all treatment being completed 6 months prior to enrollment, unless at least 5 years have elapsed since last treatment and the patient is considered cured).
  • Active bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
  • Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
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  • Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment.
  • Pre-existing neuropathy ≥ grade 2 from any cause.
  • Patients with unstable metastasis to the central nervous system (CNS). A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement.
  • Pregnant or lactating women; women of child bearing potential must have a negative serum pregnancy test within 7 days of trial registration. Women or men of child bearing potential must use effective contraception (defined by the treating physician) which must be documented in study CRFs.
  • History of allergic reaction to planned study medications.
  • Patient has a ≥ 20% decrease in serum albumin level between baseline visit, if available, and within 72 hours prior to first study treatment dose.
  • Patient is on coumadin.
  • History of interstitial lung disease.
  • History of connective tissue disorders (e.g. lupus, scleroderma, polyarteritis nodosa).
  • Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
  • Any significant medical condition, laboratory abnormality, or psychiatric illness, that would prevent the subject from participating in the study, places the subject at unacceptable risk if he/she were to participate in the study, or any condition that confounds the ability to interpret data from the study.
  • Positive Her2/neu status (NOTE: if this is discovered after patient has already been enrolled on study, patient may continue on study per the discretion of the treating physician.)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Cross Cancer Institute

    Edmonton, Alberta

Other trials in Canada

About this study

Official title: A Study to Evaluate the Safety and Feasibility of Irinotecan, Trifluridine/Tipiracil (TAS-102), and Oxaliplatin (iTTo) for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

This study will evaluate the safety and feasibility of Irinotecan, Trifluridine/Tipiracil (TAS-102) and Oxaliplatin (iTTo) for treatment naïve advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
Irinotecan, Oxaliplatin, TAS 102 (Trifluridine/Tipiracil)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrinotecanDrug

    Also called Camptosar

    Irinotecan is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase I inhibitor."

  • OxaliplatinDrug

    Also called Eloxatin

    Oxaliplatin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Oxaliplatin is classified as an "alkylating agent."

  • TAS 102 (Trifluridine/Tipiracil)Drug

    Also called Lonsurf

    Trifluridine/Tipiracil is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an antimetabolite/pyrimidine analog; antimetabolite/thymidine phosphorylase inhibitor

Study groups in NCT04808791
Study groupRoleWhat they receive
Single Arm iTTO treatmentExperimentalPatients will receive the combination of irinotecan, TAS-102, and Oxaliplatin on a 28 day cycle with the following doses; * Irinotecan 160mg/m2 IV infusion over 60-90 mins on day 1 * Oxaliplatin 100mg/m2 IV infusion over 2 hours on day 1 * TAS-102 (Trifluridine/Tipiracil) 25mg/m2 twice a day, on days 1-5 and 8-12 every 28days.
Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: TAS 102 (Trifluridine/Tipiracil)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study

    The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study.

    Measured: 1 year after enrolment of last participant.

  2. Safety/Tolerability

    Treatment related and non-related adverse events per CTCAE v.5.0 of iTTo for the treatment of advanced gastric and GEJ cancers. Incidence of adverse events, the number of dose modifications and discontinuations due to adverse events.

    Measured: Through study completion, up to 2 years.

Secondary outcomes (3)

  1. Objective Response Rate

    Defined as the proportion of participants achieving either a partial response or a complete response as best-overall response per RECIST criteria 1.1

    Measured: 1 year after enrollment of last participant.

  2. Progression Free Survival

    Defined as the time between the date of treatment initiation and the date of disease progression or death.

    Measured: 5 years from final study drug dose.

  3. Overall Survival

    Defined as the time between the date of treatment initiation and the date of death.

    Measured: 5 years from final study drug dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start27 Oct 2021
  3. Primary completion7 Jul 2023
  4. Study completion21 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single arm, interventional study combining Irinotecan, Trifluridine/Tipiracil (TAS-102), and Oxaliplatin (iTTo)
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808791
Sponsor's protocol ID
IIT-0022
Status last verified
Jun 2024
First submitted
18 Mar 2021
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Oxaliplatin and TAS 102 (Trifluridine/Tipiracil) in people with Gastroesophageal Junction Adenocarcinoma and Advanced Gastric Carcinoma, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study (time frame: 1 year after enrolment of last participant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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