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New treatment option for Metastatic Appendiceal Adenocarcinoma
Official title A Phase I/II Study of Intraperitoneal Paclitaxel in Patients With Metastatic Appendiceal Adenocarcinoma
ClinicalTrials.gov ID: NCT06207305
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, being studied as a potential treatment for metastatic appendiceal adenocarcinoma.
Also referred to as Decadron.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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: leukocytes ≥3000/mcL absolute neutrophil count ≥1,500/mcL platelets...
You likely can't join if
- 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)
- Participants with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of...
- Previous surgery that would preclude safe diagnostic laparoscopy with port placement
- Participants who have not recovered from adverse events (AE) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the...
See the full eligibility 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: leukocytes ≥3000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥75,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN)...
- 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...
- Participants with metastases outside the peritoneal cavity are not eligible for enrollment
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- The effects of PTX on the developing human fetus are unknown. For this reason, and because Taxane agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing...
- 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)
- 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...
- Ability to understand and the willingness to sign a written informed consent document 14) English and non-English-speaking participants
- 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)
- Participants with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant...
- Previous surgery that would preclude safe diagnostic laparoscopy with port placement
- Participants who have not recovered from adverse events (AE) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia
- Participants who are receiving any other investigational agents
- Participants with metastases outside the peritoneal cavity
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTX or other agents used in study
- Participants with psychiatric illness/social situations that would limit compliance with study requirements Participants who are pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.