Recruiting
Phase 2

Paclitaxel & Gastrectomy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05977998

Conditions

Gastric Adenocarcinoma

Carcinomatosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Dexamethasone

Diphenhydramine

Famotidine

Study Details

Brief summary:

To learn about the effects of paclitaxel and gastrectomy (surgery to remove all or part of the stomach) on improving outcomes in patients with gastric cancer.

Conditions

Gastric Adenocarcinoma

Carcinomatosis

Study ID

NCT05977998

Start date

Sep 8, 2023

Status verified date

May, 2026

Completion date

Oct 31, 2030

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years and above. There will be no upper age restriction. Because no dosing or adverse event data are currently available on the use of intraperitoneal paclitaxel in patients <18 years of age, children are excluded from this study.
2. ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
4. Adequate renal, and bone marrow function:

1. Leukocytes >= 3,000/uL
2. Absolute neutrophil count >= 1,500/uL
3. Platelets >= 60,000/Ul
4. Serum creatinine <= 1.6 mg/dL
5. Distant Metastatic Disease of peritoneum:

1. Positive peritoneal cytology, or
2. Carcinomatosis on diagnostic laparoscopy or laparotomy.
6. Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
7. English and non-English speaking patients are eligible.

Exclusion Criteria:

1. Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
2. Infections such as pneumonia or wound infections that would preclude protocol therapy.
3. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who are not postmenopausal defined as no menses in greater than or equal to 12 months, have not had a hysterectomy or bilateral salpingo-oophorectomy, do not have ovarian failure, or have not had a surgical sterilization procedure) must agree to refrain from breast-feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence. Men with reproductive potential must agree to an appropriate method of birth control, including abstinence or double barrier method (diaphragm plus condom).
4. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
5. Subjects, such as those with cognitive impairment, deemed unable to comply with study and/or follow-up procedures.
6. Subjects 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.
7. Previous surgery that would preclude safe cytoreduction and intraperitoneal port placement.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Paclitaxel

Participant will receive paclitaxel every 2 weeks for 6 weeks, and then participants may have a gastrectomy based on what the doctor thinks is in your best interest. You may then receive additional paclitaxel every 2 weeks for 6 weeks.

Interventions

Paclitaxel

Given by IP (Intraperitoneal injection)

Dexamethasone

Given by IV (vein)

Diphenhydramine

Given by IV (vein)

Famotidine

Given by IV (vein)

Primary outcome measure

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average 1 year. ]

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Brian Badgwell, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-22.