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Gastric CancerPhase 1NCT05379790

Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

A Phase 1 study testing Irinotecan and CAPOX in people with Gastric Cancer and Peritoneal Metastases, run by Erasmus Medical Center at 2 sites in Netherlands.

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

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Peritoneal Metastases
What is being tested?
Irinotecan and CAPOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesNetherlands
Study dates
25 May 2022to 17 Feb 2025
Phase
Phase 1
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 with a histologically confirmed diagnosis of HER2-negative gastric cancer.
  • A histologically confirmed diagnosis of peritoneal carcinomatosis.
  • Age ≥ 18 years old.
  • Written informed consent according to the ICH-GCP and national/local regulations.
  • A peritoneal cancer index (PCI) ≥7 evaluated by laparoscopy or laparotomy before inclusion in this trial.
  • Patients must be ambulatory: World Health Organisation (WHO) performance status 0 or 1.
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  • Life expectancy of at least 3 months.
  • Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.
  • Patients must have normal organ function and adequate bone marrow reserve as assessed by the following laboratory requirements:
  • absolute neutrophil count >1.5 * 10^9/l;
  • platelet count >100*10^9/l;
  • Hb>6.0mmol/l;
  • Bilirubin < 1.5x upper limit of normal (ULN);
  • Serum aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 x ULN;
  • Glomerular Filtration Rate (GFR) >45 and Creatinine clearance <2 x ULN.

Who cannot join

  • Medical or psychological impediment to probable compliance with the protocol.
  • Serious concomitant disease or active infections.
  • Distant metastasis other than peritoneal metastasis or metastatic lymph nodes.
  • No sufficient oral food intake.
  • Polyneuropathy grade 2 or worse according to CTCAE version 5.0.
  • History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis.
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  • Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for participation in this study.
  • Homozygous UGT1A1*28 genotype.
  • Homozygous dihydropyrimidine dehydrogenase (DPYD) genotype (tested for *2A, *13, 2846A>T, and 1236G>A).
  • Current use of strong CYP3A4-inhibitors or inducers. If patients use this CYP3A4-modulating medication, it is allowed to stop it within 14 days of start of treatment.
  • Pregnant or lactating women.
  • Concomitant participation in a competing clinical study.
  • Absence of assurance of compliance with the protocol.
  • An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Catharina Hospital

    Eindhoven

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously.

Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.

Being tested
Irinotecan, CAPOX
Keywords
Peritoneal metastases, Gastric cancer, Intraperitoneal, Irinotecan
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • IrinotecanDrug

    Also called Intraperitoneal irinotecan

    3 weekly IP irinotecan (max 6 cycles), dose via dose-escalation design as specified per arm.

  • CAPOXDrug

    Capecitabine 1000 mg/m2 twice daily day 1-14 (per os), and Oxaliplatin 130 mg/m2 on day 1 IV infusion.

Study groups in NCT05379790
Study groupRoleWhat they receive
Intraperitoneal irinotecan 50 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 1 50 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX
Intraperitoneal irinotecan 75 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 2 75 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX
Intraperitoneal irinotecan 100 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 3 100 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX
Intraperitoneal irinotecan 150 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 4 150 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX
Intraperitoneal irinotecan 200 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 5 200 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX
Intraperitoneal irinotecan 250 mg + CAPOXExperimentalIntraperitoneal irinotecan, dose level 6 250 mg flat dose + oral capecitabine and systemic oxaliplatin (CAPOX) (dose via standard of care)
Receives: Drug: Irinotecan; Drug: CAPOX

What is being measured

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

  1. Maximum-tolerated dose

    The maximum tolerable dose and recommended phase II dose of intraperitoneal irinotecan added to systemic chemotherapy (capecitabine/oxaliplatin)

    Measured: 18 weeks

Secondary outcomes (2)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Toxicity graded according to the CTCAE v.5.0 determined at every cycle by the medical oncologist. Toxicity will be summarized descriptively.

    Measured: 18 weeks

  2. Area Under the Curve (AUC) ratio intraperitoneal/systemic irinotecan

    During the first irinotecan intraperitoneal cycle, pharmacokinetic measurements wil be obtained. These will be withdrawn at specific time-points, namely prior to infusion, at the end of the intraperitoneal infusion, ass well as 30 minutes, 1, 1.5, 2, 3, 4, 6, and 24 hours post infusion. Blood samples from a peripheral venous catheter and peritoneal fluid will be drawn from the peritoneal access port. We assume that the AUC of irinotecan and SN-38 follow a log-normal distribution. Therefore, the analysis will be performed on log-transformed data. The antilog will be taken from the ratio and corresponding 95% confidence interval boundaries will be reported.

    Measured: 3 weeks

Timeline

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

  1. First posted18 May 2022
  2. Study start25 May 2022
  3. Primary completion25 Nov 2024
  4. Study completion17 Feb 2025

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A classic phase I '3+3' dose-escalation study.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05379790
Sponsor's protocol ID
NL79619.078.21
Status last verified
Mar 2025
First submitted
25 Apr 2022
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Irinotecan and CAPOX in people with Gastric Cancer and Peritoneal Metastases, run by Erasmus Medical Center at 2 sites in Netherlands.

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 15 inclusion and 14 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Maximum-tolerated dose (time frame: 18 weeks). 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 NCT05379790.

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 1 Apr 2025.

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