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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

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)

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: 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

~1170

Paclitaxel

2011

Completed Phase 4

~5450