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Anti-metabolites
Perioperative Paclitaxel for Stomach Cancer
Phase 2
Recruiting
Led By Brian Badgwell, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average 1 year.
Awards & highlights
Study Summary
This trial examines how paclitaxel and gastrectomy can improve outcomes in gastric cancer patients.
Who is the study for?
This trial is for adults with gastric adenocarcinoma and either positive peritoneal cytology or carcinomatosis. Participants must have completed preoperative chemotherapy, have adequate organ function, and not be pregnant or breastfeeding. They should also agree to use effective contraception. Excluded are those with severe heart conditions, life-threatening reactions to certain chemotherapies, infections that could interfere with the study, other distant metastases outside the peritoneum, or previous surgeries preventing safe treatment.Check my eligibility
What is being tested?
The trial studies the effects of paclitaxel (a chemotherapy drug) combined with gastrectomy (surgical removal of all or part of the stomach) on patients with gastric cancer. It aims to understand how this combination can improve patient outcomes.See study design
What are the potential side effects?
Paclitaxel may cause side effects like allergic reactions, blood disorders such as low white cell count increasing infection risk, nerve damage leading to numbness or pain in hands/feet (neuropathy), muscle and joint pain, nausea/vomiting controlled by medications like dexamethasone and famotidine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: PaclitaxelExperimental Treatment4 Interventions
Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Diphenhydramine
2002
Completed Phase 4
~1170
Famotidine
2005
Completed Phase 4
~1700
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,444 Total Patients Enrolled
Brian Badgwell, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had surgery that makes it unsafe to remove my tumor or place a port in my belly.I do not have infections like pneumonia that would stop me from following the treatment plan.I am a man who can father children and agree to use birth control.I can communicate in English or another language.My cancer has spread to organs like the liver, brain, or lungs.My cancer is confirmed to be adenocarcinoma in the stomach or where the stomach meets the esophagus.I am 18 years old or older.I can take care of myself but may not be able to do active work.My blood tests show my bone marrow is working well.My cancer has spread to the lining of my abdomen with confirmed test results.My kidney function is good (creatinine <= 1.6 mg/dL).I have finished my chemotherapy before surgery.I can follow the study's requirements and attend all follow-ups.I have severe heart issues, like unstable chest pain or significant heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Paclitaxel
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 does Paclitaxel impact the safety of those treated with it?
"Paclitaxel has been deemed relatively safe by the Power team, receiving a 2 on their safety scale. This is due to it being in Phase 2 clinical trials, where there is existing evidence of its security but yet no proof of efficacy."
Answered by AI
Is this medical experiment currently seeking participants?
"Based on the information found on clinicaltrials.gov, this particular study is not currently recruiting patients as it was last modified in August 7th 2023. Nevertheless, there are 3182 other medical trials actively looking for volunteers at this moment."
Answered by AI
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