Actively Recruiting
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-01-13
39
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the recommended dose of the drug paclitaxel that can be given intraperitoneally (given directly into the abdominal cavity) to participants with metastatic appendiceal adenocarcinoma.
CONDITIONS
Official Title
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and above with no upper age limit
- ECOG performance status of 2 or less
- Histologically confirmed unresectable locally metastatic appendiceal adenocarcinoma
- Metastatic disease confined to the peritoneal cavity and not eligible for cytoreductive surgery
- Adequate organ and marrow function including leukocytes 6000/mcL, absolute neutrophil count 1,500/mcL, platelets 75,000/mcL, total bilirubin within normal limits, and creatinine 1.5 times institutional upper limit
- Undetectable hepatitis B viral load on suppressive therapy if applicable
- Participants with hepatitis C must be treated and cured or have undetectable viral load if on treatment
- No metastases outside the peritoneal cavity
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
- Women of child-bearing potential and men must agree to use effective contraception during and after the study
- Ability to understand and sign informed consent
- Includes English and non-English speaking participants
You will not qualify if you...
- Active infections such as pneumonia or wound infections that prevent treatment
- Unstable angina or moderate to severe congestive heart failure (NYHA Grade II or higher)
- Inability to comply with study or follow-up procedures such as cognitive impairment
- Life-threatening or severe allergic reactions to chemotherapy used in the study
- Previous surgeries preventing safe diagnostic laparoscopy with port placement
- Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 except hair loss
- Receiving other investigational agents
- Metastases outside the peritoneal cavity
- Allergic reactions to paclitaxel or similar agents
- Psychiatric or social issues limiting compliance
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77303
Actively Recruiting
Research Team
B
Beth Helmink, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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