A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocar… (NCT06207305) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
United States39 participantsStarted 2024-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years and above. There will be no upper age restriction
✓. ECOG performance status ≤ 2
✓. Participants must have histologically confirmed diagnosis of unresectable locally metastatic appendiceal adenocarcinoma
✓. Metastatic disease in the peritoneal cavity and not a candidate for cytoreductive surgery
✓. Participants must have adequate organ and marrow function as defined below:
✓. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
✓. 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
✓. Participants with metastases outside the peritoneal cavity are not eligible for enrollment
Exclusion criteria
✕. Postmenopausal (no menses in greater than or equal to 12 consecutive months)
✕. History of hysterectomy or bilateral salpingo-oophorectomy
✕. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
✕
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.
. History of bilateral tubal ligation or another surgical sterilization procedure Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
✕1. Ability to understand and the willingness to sign a written informed consent document
✕. Active infection such as pneumonia or wound infections that would preclude protocol therapy
✕. Participants with unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure
✕. Participants deemed unable to comply with study and/or follow-up procedures (i.e., cognitive impairment)