Your session is about to expire
← Back to Search
Anti-microtubule agent
Intraperitoneal Chemotherapy for Stomach Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Study Summary
This trial is testing a new treatment for gastric cancer that has spread to the abdomen. The new treatment is a combination of two drugs, and this study will test how well it works.
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.Check my eligibility
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).See study design
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.
Select...
I am 18 years old or older.
Select...
My cancer has not spread to distant parts of my body as confirmed by scans.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My gastric cancer was confirmed without prior chemo for advanced stages.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Progression-Free Survival
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
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,750 Total Patients Enrolled
Fabian M Johnston, MD, MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
310 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research participants are involved in this experiment?
"Affirmative. The information located on clinicaltrials.gov indicates that this research is presently searching for volunteers. This investigation was first posted to the website in November 1st 2020 and recently updated on November 7th 2022, with a goal of enlisting 30 patients from one single medical site."
Answered by AI
Are there any other investigations that have employed Intraperitoneal docetaxel?
"Currently, 320 Intraperitoneal docetaxel trials are underway. 126 of them have reached the third phase of research and development. Most of these experiments originate in Fuzhou, Fujian; however, there are 22389 participating sites for this procedure worldwide."
Answered by AI
What are the known risks of administering Intraperitoneal docetaxel to patients?
"Our experts at Power assigned an approximate safety rating of 1 to intraperitoneal docetaxel, as this is only a Phase 1 trial and there is limited data available on its efficacy or risk profile."
Answered by AI
Are any fresh participants being admitted to this trial?
"Clinicaltrials.gov confirms that this medical trial was first made public on November 1st 2020 and is currently recruiting participants. The listing of the study has been updated as recently as November 7th 2021."
Answered by AI
What health issues is Intraperitoneal docetaxel commonly administered for?
"Intraperitoneal docetaxel is a widely used medication for the treatment of malignant cancerous growths. It can also be deployed to treat more specific conditions such as esophageal neoplasms, sarcoma, and advanced directives."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Texas
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Johns Hopkins University
Why did patients apply to this trial?
Your work and trial addresses the spread to Peritoneal and want to target treatment . (gastric cancer stage 4 diagnosed Apr 2022) tried drugs, chemotherapy and removal of ovaries (this year two separate surgeries).
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What are the side effects of intraperitoneal docetaxel?
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger