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

NCT06207305 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2023-0860NCI-2024-00080
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Appendiceal Adenocarcinoma; Intraperitoneal Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Phase I/Phase II

EXPERIMENTAL

Participants will be assigned to a study phase (Phase I or Phase II) based on when participants join this study. Up to 4 groups of at least 3 participants will be enrolled in Phase I of the study, and up to 15 participants will be enrolled in Phase II. If you are enrolled in Phase I, the dose of paclitaxel you receive will depend on when the participants join this study. The first group of participants will receive the lowest dose level of paclitaxel. Each new group will receive a higher dose of paclitaxel than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel given intraperitoneally is found. Participants who are enrolled in Phase II, participants will receive paclitaxel at the recommended dose that was found in Phase I.

Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Famotidine; Drug: Paclitaxel

Interventions

Dexamethasone DRUG

Given by PO

Also known as: Decadron

Phase I/Phase II

Diphenhydramine DRUG

Given by PO

Also known as: Benadryl®

Phase I/Phase II

Famotidine DRUG

Given by PO

Also known as: Pepcid®

Phase I/Phase II

Paclitaxel DRUG

Given by PO

Also known as: Taxol

Phase I/Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 ≥75,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) creatinine ≤ 1.5X institutional 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 viral load
• 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 efficacy assessment of the investigational regimen are eligible for this trial
• 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, 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.
• Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of paclitaxel administration.

You may not qualify 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 existing hospitalization, or resulted in persistent or significant disability or incapacity
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77303, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Adenocarcinoma, Mucinous

Interventions

Dexamethasone; Calcium Dobesilate; Diphenhydramine; Famotidine; Paclitaxel

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Ethylamines; Amines; Benzhydryl Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Beth Helmink, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Helmink, MD

CONTACT

(832) 696-5784; bhelmink@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)