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Platinum-containing compound

Paclitaxel for Gastrointestinal Disorders

Phase 1
Waitlist Available
Led By Brian D. 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 3 to 7 days after hyperthermic intraperitoneal chemotherapy (hipec) infusion
Awards & highlights

Study Summary

This trial is studying a combination of paclitaxel, mitomycin, and cisplatin given as hyperthermic intraperitoneal chemotherapy (HIPEC) to find the best dose to control gastric or gastroesophageal cancer.

Eligible Conditions
  • Gastrointestinal Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 7 days after hyperthermic intraperitoneal chemotherapy (hipec) infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 7 days after hyperthermic intraperitoneal chemotherapy (hipec) infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
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: Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)Experimental Treatment6 Interventions
Participants receive heated Mitomycin, Cisplatin, and Paclitaxel as a liquid that is injected through 3 to 4 small incisions into the abdomen over about 1 hour.
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
Mitomycin C
2019
Completed Phase 4
~820
Cisplatin
2013
Completed Phase 3
~1940
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,959 Previous Clinical Trials
1,798,416 Total Patients Enrolled
Brian D. Badgwell, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical conditions is Paclitaxel typically recommended as a treatment?

"Paclitaxel is a widely-used medication administered to patients weighing 40 kg or more. Its potential applications extend beyond this, as it has proven useful in managing helicobacter pylori infection, synovitis and metastatic bladder cancer."

Answered by AI

Is acceptance for individual participation in this trial still ongoing?

"The evidence on clinicaltrials.gov suggests that this research initiative is no longer actively recruiting participants, having been initially posted in October of 2017 and last updated in September 2021. However, there are presently 5140 other studies searching for patients across the United States."

Answered by AI

Has the FDA given its stamp of approval to Paclitaxel?

"Paclitaxel's safety is estimated to be a 1 due to limited evidence regarding its efficacy and safety, as this trial falls under the Phase 1 designation."

Answered by AI

How many individuals are actively involved in this clinical experiment?

"Unfortunately, this clinical research is no longer recruiting patients. As per the information on clinicaltrials.gov, it was initially posted on October 27th 2017 and last updated September 7th 2022. However, there are presently 3297 other trials with fever as an inclusion criteria and 1923 studies examining Paclitaxel that are still admitting participants."

Answered by AI
~4 spots leftby Mar 2025