NCT06207305

A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 treatment is to provide a possible therapeutic benefit, and thus the participants will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability 2. To assess the pharmacokinetics of IP PTX 3. To assess the change in PCI following IP PTX in patients with metastatic appendiceal adenocarcinoma 4. To assess rate of initially unresectable participants with metastatic appendiceal adenocarcinoma able to undergo CRS / HIPEC after IP PTX 5. To assess the rate of conversion from positive to negative cytology in peritoneal fluid following IP PTX in participants with metastatic appendiceal adenocarcinoma 6. To assess the prognostic value of circulating tumor DNA (ctDNA) in participants with metastatic appendiceal adenocarcinoma and the correlation of quantitative ctDNA measurement with radiographic and pathologic response 7. To generate PDX and PDO models of appendiceal adenocarcinoma and evaluate their ability to predict response of human tumors 8. To evaluate the effect of IP PTX on the transcriptomic state of appendiceal adenocarcinoma and the tumor microenvironment (TME) through comparison of pre- and post-treatment specimens 9. To assess the impact of GNAS, KRAS, TP53, and APC mutation on response to IP PTX therapy 10. To assess the impact of mucinous, signet ring cell, and goblet cell histology on response to IP PTX therapy

Conditions

• Metastatic Appendiceal Adenocarcinoma
• Intraperitoneal Paclitaxel

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given by PO
DRUG	Diphenhydramine	Given by PO
DRUG	Famotidine	Given by PO
DRUG	Paclitaxel	Given by PO

Timeline

• Start date: 2024-01-30
• Primary completion: 2028-01-02
• Completion: 2028-01-02
• First posted: 2024-01-16
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study