Study on Intraperitoneal Paclitaxel for Patients with Advanced Appendiceal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06207305

Provider View

This clinical trial is testing the safety and effectiveness of delivering the chemotherapy drug paclitaxel directly into the abdomen for patients with advanced appendiceal cancer that has spread within the abdominal cavity.

Patient Parameters

Program Overview

The aim of this study is to find the best dose of paclitaxel that can be safely given directly into the abdominal cavity for patients with advanced appendiceal cancer. Researchers want to see if this method can help control the cancer and improve survival rates. Participants will be closely monitored for any side effects and changes in their cancer.

Description

This study is divided into two phases. In Phase I, researchers will determine the highest dose of paclitaxel that can be safely given directly into the abdomen every two weeks to patients with advanced appendiceal cancer. In Phase II, they will evaluate how well this treatment works in shrinking tumors and improving survival rates.

Secondary goals include monitoring how long patients live without the cancer getting worse, understanding how the drug moves through the body, and seeing if the treatment makes surgery possible for tumors that couldn't be removed before. Researchers will also study changes in cancer cells and the surrounding environment before and after treatment, and how certain genetic mutations affect the response to the treatment.

Participants will undergo various tests and procedures to ensure they meet the study criteria and to monitor their health throughout the trial. The study aims to provide insights into whether this treatment approach can offer benefits for patients with advanced appendiceal cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced appendiceal cancer that cannot be surgically removed.
  • Cancer must be within the abdominal cavity and not suitable for surgery.
  • Have good organ and bone marrow function based on specific blood tests.
  • If you have hepatitis B, the virus must be under control with treatment.
  • If you have had hepatitis C, it must be treated and cured.
  • Cannot have cancer spread outside the abdominal cavity.
  • Must agree to use effective birth control during the study and for a period after.
  • Must be able to understand and sign a consent form.
  • Both English and non-English speakers are eligible.

Exclusion Criteria

  • Have an active infection that would prevent participation.
  • Have serious heart conditions like unstable angina or severe heart failure.
  • Unable to follow study procedures due to cognitive issues.
  • Have severe allergies to chemotherapy drugs used in the study.
  • Have had surgery that prevents safe participation in the study.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Are taking other experimental drugs.
  • Have cancer spread outside the abdominal cavity.
  • Have a history of severe allergic reactions to similar drugs.
  • Have psychiatric or social issues that would prevent following the study requirements.
  • Are pregnant.

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