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Anti-metabolites

Intraperitoneal Paclitaxel for Appendiceal Cancer

Phase 1 & 2
Recruiting
Led By Beth Helmink, 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
ECOG performance status ≤ 2
Participants must have histologically confirmed diagnosis of unresectable locally metastatic appendiceal adenocarcinoma
Must not have
Participants with unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure
Participants deemed unable to comply with study and/or follow-up procedures (i.e., cognitive impairment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

This trial is trying to determine how much of the drug paclitaxel can be safely given directly into the abdominal cavity to patients with a specific type of cancer.

Who is the study for?
This trial is for individuals with metastatic appendiceal adenocarcinoma, which is a type of cancer that affects the appendix and has spread to other areas. The study aims to find participants who can receive paclitaxel directly into their abdominal cavity.
What is being tested?
The study is testing the administration of paclitaxel directly into the abdomen along with pre-medications like Diphenhydramine, Dexamethasone, and Famotidine. It's in phases I/II to determine the safest dose for patients.
What are the potential side effects?
Paclitaxel may cause side effects such as allergic reactions, pain at injection site, nausea, vomiting, hair loss, muscle or joint pain. Pre-medications are given to reduce these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 a type of appendix cancer that cannot be surgically removed.
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My cancer has spread to the abdominal area and I cannot have surgery to remove it.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B virus load is undetectable with treatment.
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My blood counts and kidney and liver functions are within normal ranges.

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, including unstable chest pain or significant heart failure.
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I am able to follow the study's procedures and attend all required appointments.
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I've had surgery that makes it unsafe to have a diagnostic laparoscopy.
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I do not have an active infection like pneumonia.
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My cancer has spread outside the abdominal lining.
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I've had a severe allergic reaction to chemotherapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I/Phase IIExperimental Treatment4 Interventions
Participants will be assigned to a study phase (Phase I or Phase II) based on when participants join this study. Up to 4 groups of at least 3 participants will be enrolled in Phase I of the study, and up to 15 participants will be enrolled in Phase II. If you are enrolled in Phase I, the dose of paclitaxel you receive will depend on when the participants join this study. The first group of participants will receive the lowest dose level of paclitaxel. Each new group will receive a higher dose of paclitaxel than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel given intraperitoneally is found. Participants who are enrolled in Phase II, participants will receive paclitaxel at the recommended dose that was found in Phase I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
2002
Completed Phase 4
~1140
Famotidine
2005
Completed Phase 4
~1700
Dexamethasone
2007
Completed Phase 4
~2640
Paclitaxel
2011
Completed Phase 4
~5810

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,662 Total Patients Enrolled
Beth Helmink, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~25 spots leftby Jan 2026
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