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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
Must not have
Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure
Previous surgery that would preclude safe diagnostic laparoscopy with port placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to after 30 days after treatment completion
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My cancer has spread to the lining of my abdomen.
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I have finished my chemotherapy before surgery.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is confirmed to be in the stomach or where the stomach meets the esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart issues, like unstable chest pain or significant heart failure.
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I've had surgery that makes it unsafe to have a diagnostic laparoscopy.
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I am not pregnant, not breastfeeding, and agree to use birth control.
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I've had a severe allergic reaction to chemotherapy before.
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I do not have infections like pneumonia that would stop me from following the treatment plan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to after 30 days after treatment completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to after 30 days after treatment completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
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

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: 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
~5450

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,800 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,210 Total Patients Enrolled
Brian D BadgwellPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

Paclitaxel (Mitotic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04220827 — Phase 1
Esophageal cancer Research Study Groups: Treatment (paclitaxel)
Esophageal cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT04220827 — Phase 1
Paclitaxel (Mitotic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04220827 — Phase 1
~12 spots leftby Oct 2028
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