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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 belowSelect...
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:Select...
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
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
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.
[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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,898 Total Patients Enrolled
Fabian M Johnston, MD, MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use contraception during and for 4 months after the study.I have active Hepatitis B or C.I have had a transplant from a donor.I am willing to have a port placed inside my abdomen.I am 18 years old or older.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I have been diagnosed with HIV.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am not taking drugs that affect the enzyme CYP3A4.I do not have any known heart problems.I have received radiotherapy in my pelvic or abdominal area.I am using two birth control methods or am not having sex to join this study.My organ functions are normal as per recent tests.My gastric cancer affects the area near my esophagus or the beginning of my small intestine.My tumor is HER2 positive.I am currently taking antibiotics for an infection.My cancer has not spread to distant parts of my body as confirmed by scans.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or treated cervical cancer.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment in the last 4 weeks, or I've recovered from its side effects.My gastric cancer was confirmed without prior chemo for advanced stages.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My cancer has spread to my brain or its coverings.I am not allergic to docetaxel or mFOLFOX6.I have had surgery before that resulted in thick scar tissue inside my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Intraperitoneal docetaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.