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

NCT05977998 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0331NCI-2023-05915
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 1 year.

Study Arms (1)

Paclitaxel

EXPERIMENTAL

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

Interventions

Paclitaxel DRUG

Given by IP (Intraperitoneal injection)

Also known as: Taxol

Paclitaxel

Dexamethasone DRUG

Given by IV (vein)

Also known as: Decadron

Paclitaxel

Diphenhydramine DRUG

Given by IV (vein)

Also known as: Benadryl®

Paclitaxel

Famotidine DRUG

Given by IV (vein)

Also known as: Pepcid®

Paclitaxel

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. 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.
• ECOG performance status ≤ 2 (Karnofsky ≥60%). Appendices 1 and 2.
• Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
• Adequate renal, and bone marrow function:
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 60,000/Ul
• Serum creatinine \<= 1.6 mg/dL
• Distant Metastatic Disease of peritoneum:
• Positive peritoneal cytology, or
• Carcinomatosis on diagnostic laparoscopy or laparotomy.
• Completion of preoperative systemic cytotoxic chemotherapy. Targeted therapy, such as HER2 directed therapy, and immunotherapy, such as PD-1 inhibitors, may be continued.
• English and non-English speaking patients are eligible.

You may not qualify if:

• Distant metastatic disease not limited to the peritoneum such as solid organ metastases to the liver, central nervous system, or lung.
• 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-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).
• Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
• Subjects, such as those with cognitive impairment, 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 cytoreduction and intraperitoneal port placement.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma

Interventions

Paclitaxel; Dexamethasone; Calcium Dobesilate; Diphenhydramine; Famotidine

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Brian Badgwell, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iqra Rehman, RN

CONTACT

713-535-0703; IRehman1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 7, 2023
• Study Start: September 8, 2023
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2030
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)