A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
M.D. Anderson Cancer Center
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.
Description
Primary (Phase I): 1. To assess the maximum tolerated dose (MTD) of paclitaxel via IP route given every 14 days in subjects with metastatic appendiceal adenocarcinoma Primary (Phase II): 2. To assess the pathologic and radiographic objective response rate of paclitaxel via IP route in participants with metastatic appendiceal adenocarcinoma Secondary Objectives 1. To assess the progression-free and overall survival of metastatic appendiceal adenocarcinoma treated with IP paclitaxel. Although the clinical benefit of this drug has not yet been established, the intent of offering this treat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 years and above. There will be no upper age restriction 2. ECOG performance status ≤ 2 3. Participants must have histologically confirmed diagnosis of unresectable locally metastatic appendiceal adenocarcinoma 4. Metastatic disease in the peritoneal cavity and not a candidate for cytoreductive surgery 5. Participants must have adequate organ and marrow function as defined below: leukocytes ≥3000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥75,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) creatinine ≤ 1.5X institutional ULN 6. For…
Interventions
- DrugDexamethasone
Given by PO
- DrugDiphenhydramine
Given by PO
- DrugFamotidine
Given by PO
- DrugPaclitaxel
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas