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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of paclitaxel delivered directly into the abdominal cavity (intraperitoneal) for people with metastatic appendiceal adenocarcinoma, a cancer that has spread within the abdomen and cannot be removed by surgery. This Phase I/II trial aims to find the safest and most effective dose of paclitaxel given every 14 days and to evaluate its effects on tumor response and patient outcomes. The study also explores various biological markers and tumor characteristics to better understand treatment response. Participants are assigned to either Phase I or Phase II based on when they join the study. In Phase I, small groups receive increasing doses of paclitaxel intraperitoneally to identify the maximum tolerated dose. Phase II participants receive the recommended dose found in Phase I. Additional medications like dexamethasone, diphenhydramine, and famotidine are given orally to support treatment. The study monitors tumor changes, survival, and biological markers over time. During the study, participants will be carefully monitored for safety and side effects for about one year. Researchers will assess tumor response using pathology and imaging, measure pharmacokinetics of the drug, and track clinical outcomes such as progression-free and overall survival. Participants will undergo regular evaluations and provide samples to study tumor behavior and treatment effects. The study continues until January 2028, allowing long-term observation of treatment impact and safety.
CONDITIONS
Brief 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 metastatic appendiceal adenocarcinoma
- Metastatic disease limited to the peritoneal cavity and not a candidate for cytoreductive surgery
- Adequate organ and marrow function including leukocytes 2000/mcL, absolute neutrophil count 1,500/mcL, platelets 75,000/mcL, total bilirubin within institutional normal limits, and creatinine 1.5 times institutional normal limit
- For chronic hepatitis B, viral load must be undetectable on therapy if required
- Hepatitis C must be treated and cured or have undetectable viral load if on treatment
- No metastases outside the peritoneal cavity
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
- Women of childbearing potential and men must agree to use adequate contraception during and after study participation
- Ability to understand and willingness to sign informed consent
- English and non-English speaking participants included
You will not qualify if you...
- Active infections such as pneumonia or wound infections that prevent protocol therapy
- Unstable angina or congestive heart failure NYHA Grade II or greater
- Inability to comply with study or follow-up procedures due to cognitive impairment
- Known life-threatening hypersensitivity to systemic chemotherapy used in the study
- Previous surgery preventing safe diagnostic laparoscopy with port placement
- Unresolved adverse events from prior anti-cancer therapy greater than Grade 1 (except alopecia)
- Receiving other investigational agents
- Metastases outside the peritoneal cavity
- History of allergic reactions to paclitaxel or similar compounds
- Psychiatric illness or social situations limiting study compliance
- Pregnancy at time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated every 14 days until disease progression or discontinuation
Participants receive intraperitoneal paclitaxel every 14 days to treat metastatic appendiceal adenocarcinoma. Dose depends on study phase and tolerance.
Visits every 2 weeks for paclitaxel administration
Duration - Up to 1 year
Participants are monitored for safety, tumor response, and symptom relief following treatment completion.
Regular follow-up visits during the year after treatment
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77303
Actively Recruiting
Research Team
B
Beth Helmink, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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