A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

May 19, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after perioperative intraperitoneal paclitaxel and gastrectomy.

Secondary Objectives:

To assess the safety of gastrectomy in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis undergoing treatment with perioperative intraperitoneal paclitaxel.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Brian Badgwell, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Paclitaxel
Given by IP (Intraperitoneal injection)
Other Names:
  • Taxol
Drug: Dexamethasone
Given by IV (vein)
Other Names:
  • Decadron
Drug: Diphenhydramine
Given by IV (vein)
Other Names:
  • Benadryl®
Drug: Famotidine
Given by IV (vein)
Other Names:
  • Pepcid®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
through study completion; an average 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Brian Badgwell, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0331
  • NCI-2023-05915 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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