Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

April 10, 2026 updated by: M.D. Anderson Cancer Center

A Phase I Study of Intraperitoneal Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

This phase I trial studies the side effects and best dose of paclitaxel for the treatment of gastric or gastroesophageal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the maximum tolerated dose (MTD) of paclitaxel via intraperitoneal route in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

SECONDARY OBJECTIVES:

I. Safety and tolerability of escalating doses of intraperitoneal paclitaxel in subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

II. To make a preliminary assessment of the anti-tumor activity of paclitaxel in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

OUTLINE: This is a dose-escalation study.

Patients receive paclitaxel intraperitoneally (IP) over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 60,000/Ul
  • Serum creatinine =< 1.5 mg/dL

  • Distant metastatic disease of peritoneum:

    • Positive peritoneal cytology
    • Carcinomatosis on diagnostic laparoscopy or laparotomy
    • Completion of preoperative systemic chemotherapy

Exclusion Criteria:

  • Infections such as pneumonia or wound infections that would preclude protocol therapy
  • 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-ophorectomy, 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)
  • Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure
  • Subjects deemed unable to comply with study and/or follow-up procedures
  • 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
  • Previous surgery that would preclude safe diagnostic laparoscopy with 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: Treatment (paclitaxel)
Patients receive paclitaxel IP over 1 hour once weekly during weeks 1-3 and 5-7 in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel
Given IP
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to after 30 days after treatment completion
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Safety data will be summarized using frequency tables by grade and attribution.
Up to after 30 days after treatment completion

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brian D Badgwell, 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)

December 6, 2019

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0784 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-08320 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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