Your session is about to expire
← Back to Search
Mitotic Inhibitor
Paclitaxel for Gastric Cancer
Phase 1
Waitlist Available
Led By Brian D Badgwell
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
Distant metastatic disease of peritoneum:
Completion of preoperative systemic chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to after 30 days after treatment completion
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of paclitaxel for gastric or gastroesophageal cancer. Paclitaxel is a drug that stops the growth of tumor cells.
Who is the study for?
This trial is for adults with gastric or gastroesophageal cancer who have good physical function (ECOG <=2) and adequate blood counts. They must have completed preoperative chemotherapy, not be pregnant or breastfeeding, agree to use contraception, and can't have severe heart conditions, active infections, or life-threatening reactions to similar chemo drugs.Check my eligibility
What is being tested?
The study is testing different doses of Paclitaxel to find the safest and most effective amount for treating stomach and gastroesophageal cancers. It's a phase I trial focused on understanding side effects while trying to stop cancer cell growth by killing them or stopping their spread.See study design
What are the potential side effects?
Paclitaxel may cause side effects such as allergic reactions, low blood cell counts leading to increased infection risk and bleeding problems, nerve damage causing numbness or pain in hands/feet, muscle pains, joint pains, nausea/vomiting/diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to the lining of my abdomen.
Select...
I have finished my chemotherapy before surgery.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer is confirmed to be in the stomach or where the stomach meets the esophagus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to after 30 days after treatment completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to after 30 days after treatment completion
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
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel)Experimental Treatment1 Intervention
Patients receive paclitaxel IP over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,754 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,126 Total Patients Enrolled
Brian D BadgwellPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed to be in the stomach or where the stomach meets the esophagus.My cancer has spread to the lining of my abdomen.I have finished my chemotherapy before surgery.I can take care of myself but might not be able to do heavy physical work.I can follow the study's requirements and attend all follow-up visits.I have severe heart issues, like unstable chest pain or significant heart failure.I've had surgery that makes it unsafe to have a diagnostic laparoscopy.I am not pregnant, not breastfeeding, and agree to use birth control.I am a man who can father children and agree to use effective birth control or practice abstinence.I've had a severe allergic reaction to chemotherapy before.I do not have infections like pneumonia that would stop me from following the treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Who else is applying?
What state do they live in?
Illinois
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How long does the trial require me to stay in Houston, Texas?
PatientReceived 2+ prior treatments
Recent research and studies
Share this study with friends
Copy Link
Messenger