A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
NCT06207305 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2026-01-13
Summary
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
- Metastatic Appendiceal Adenocarcinoma
- Intraperitoneal Paclitaxel
Interventions
- DRUG
-
Given by PO
- DRUG
-
Diphenhydramine
Given by PO
- DRUG
-
Famotidine
Given by PO
- DRUG
-
Given by PO
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Beth Helmink, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-30
- Primary Completion
- 2028-01-02
- Completion
- 2028-01-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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