What side effects are associated with this type of intervention?

Intraperitoneal docetaxel, a microtubule inhibitor, can cause side effects such as neutropenia, febrile neutropenia, anemia, fatigue, and gastrointestinal issues like nausea and vomiting. Systemic mFOLFOX6, which inhibits DNA synthesis, commonly results in side effects including neutropenia, thrombocytopenia, peripheral neuropathy, mucositis, diarrhea, and hand-foot syndrome. Both treatments can lead to significant hematologic and non-hematologic toxicities, necessitating careful monitoring and supportive care.

What prior FDA approvals exist?

For the treatment of Peritoneal Carcinomatosis, FDA-approved drugs include microtubule inhibitors such as Paclitaxel and Docetaxel, which are commonly used in various chemotherapy regimens. Additionally, DNA synthesis inhibitors like 5-Fluorouracil (5-FU) and Oxaliplatin, which are components of the mFOLFOX6 regimen, are also approved for use. These drugs are often used in combination therapies to enhance efficacy and target cancer cells through different mechanisms.

What other types of research exist?

Promising novel alternatives for Peritoneal Carcinomatosis patients include: 1) Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with agents like mitomycin C or 5-FU, which has shown improved survival rates and lower recurrence rates. 2) Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with oxaliplatin, which has demonstrated feasibility and safety in treating colorectal peritoneal metastases. 3) Immunotherapy with PD-1/PD-L1 inhibitors such as pembrolizumab or avelumab, which have shown durable responses in mesothelioma and other peritoneal cancers.

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Anti-microtubule agent

Intraperitoneal Chemotherapy for Stomach Cancer

Phase 1

Waitlist Available

Led By Fabian M Johnston, MD, MHS

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Willingness to undergo intraperitoneal port placement

Be ≥ 18 years of age on day of signing informed consent

Must not have

Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C virus (e.g., Hepatitis C virus RNA [qualitative] is detected)

History of allogeneic transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for patients with stomach cancer that has spread to the abdomen. It combines a drug delivered directly into the abdomen with standard chemotherapy given through the bloodstream. The goal is to improve drug delivery and effectiveness in killing cancer cells.

Who is the study for?

Adults with confirmed gastric cancer and peritoneal carcinomatosis, without distant metastases or prior chemotherapy for recurrent disease. Participants must be willing to use two birth control methods or abstain from sex, have an ECOG performance status of 0-1, adequate organ function, and agree to intraperitoneal port placement. Exclusions include CNS metastases, HER2 positive tumors, immunodeficiency conditions, active infections requiring antibiotics, certain heart abnormalities.

What is being tested?

The trial is testing the effectiveness of delivering docetaxel directly into the abdomen in combination with systemic mFOLFOX6 chemotherapy in patients with advanced stomach cancer that has spread to the lining of the abdominal cavity (peritoneum).

What are the potential side effects?

Potential side effects may include allergic reactions to medication components; nerve damage; blood disorders; increased risk of infection due to immune system suppression; liver issues reflected in lab tests; fatigue and gastrointestinal symptoms like nausea.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to have a port placed inside my abdomen.

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I am 18 years old or older.

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My cancer has not spread to distant parts of my body as confirmed by scans.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My gastric cancer was confirmed without prior chemo for advanced stages.

Exclusion Criteria

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

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I have active Hepatitis B or C.

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I have had a transplant from a donor.

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I have been diagnosed with HIV.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I do not have any known heart problems.

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I have received radiotherapy in my pelvic or abdominal area.

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My gastric cancer affects the area near my esophagus or the beginning of my small intestine.

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My tumor is HER2 positive.

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I am currently taking antibiotics for an infection.

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My cancer has spread to my brain or its coverings.

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I am not allergic to docetaxel or mFOLFOX6.

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I have had surgery before that resulted in thick scar tissue inside my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Secondary study objectives

Progression-Free Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intraperitoneal docetaxelExperimental Treatment1 Intervention

Participants will receive intraperitoneal docetaxel combined with the standard of care. A standard 3 + 3 dose escalation design will be used according to the dose escalation plan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intraperitoneal docetaxel

2013

Completed Phase 1

~20

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peritoneal Carcinomatosis (PC) is often treated with a combination of intraperitoneal and systemic chemotherapies to maximize efficacy. Intraperitoneal docetaxel, a microtubule inhibitor, works by disrupting the microtubule network essential for cell division, leading to cell cycle arrest and apoptosis. Systemic mFOLFOX6, which includes oxaliplatin and fluorouracil, inhibits DNA synthesis and repair, further preventing cancer cell proliferation. These mechanisms are crucial for PC patients as they target cancer cells both locally within the peritoneal cavity and systemically, potentially improving survival rates and reducing tumor burden more effectively than single-agent therapies.

[Importance and problems of intraperitoneal chemotherapy].Mass Spectrometry-Based Method to Study Inhibitor-Induced Metabolic Redirection in the Central Metabolism of Cancer Cells.Enhanced efficacy of combined 213Bi-DTPA-F3 and paclitaxel therapy of peritoneal carcinomatosis is mediated by enhanced induction of apoptosis and G2/M phase arrest.