NCT06207305 A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
| NCT ID | NCT06207305 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Appendiceal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2028-01-02 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated 7. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load 8. Participants with me