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Antimetabolite

Chemotherapy for Stomach Cancer with Peritoneal Carcinomatosis (STOPGAP Trial)

Phase 2

Recruiting

Led By Maheswari Senthil, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy

Performance status: ECOG performance status ≤ 2 (Appendix A). ECOG 2 allowed is attributed to malignancy (rather than comorbidities)

Must not have

Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal)

Ongoing or active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial is testing a new way to give chemotherapy to people with stomach cancer that has spread to the lining of the abdomen.

Who is the study for?

Adults aged 18-75 with gastric or gastroesophageal junction cancer and peritoneal carcinomatosis, who've had at least three months of initial treatment without visceral metastasis. Participants need good organ function, no severe heart conditions, infections, or other cancers in the last 3 years. Pregnant women are excluded and contraception is required during the trial.

What is being tested?

The trial tests a combination of systemic chemotherapy (Leucovorin, Fluorouracil) followed by intraperitoneal Paclitaxel to see if it's safe and works for patients with stomach cancer that has spread to the lining of their abdomen.

What are the potential side effects?

Possible side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations (neuropathy), allergic reactions, and hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to the lining of my abdomen.

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My ability to perform daily activities is limited due to my cancer, not other illnesses.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant organs like the liver, lungs, or brain.

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I currently have an infection.

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I've had surgery that makes it unsafe to do certain diagnostic procedures.

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My cancer has spread to lymph nodes in my abdomen and cannot be surgically removed.

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I am currently being treated for an infection.

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I have symptoms of heart failure.

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I have an irregular heartbeat.

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I have an active tuberculosis infection.

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I have unstable chest pain.

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I have not had a stroke, heart attack, or similar event in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety]

Participants with Progression Free Survival at 1-Year

Secondary study objectives

Overall Survival of Participants

Patient Reported Quality of Life Outcomes

Other study objectives

Correlation of Plasma and Ascite Exosomal Gene Signature (EXOSIG) to Treatment Response

Expression of Plasma and Ascites Exosomal Gene Signature (EXOSIG)

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal CarcinomatosisExperimental Treatment3 Interventions

Patients will receive sequential intraperitoneal paclitaxel along with intravenous paclitaxel, 5-FU, and leucovorin on Days 1 and 8 of every 21 day cycle for 3 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Fluorouracil

FDA approved

Leucovorin

FDA approved

0 / 13Eligibility criteria met