Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT06207305
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-00080 | OTHER | NCI-CTRP Clinical Registry | View |