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

Primary Purpose

Gastric Adenocarcinoma, Carcinomatosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Dexamethasone
Diphenhydramine
Famotidine
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2023
Last Updated
September 11, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05977998
Brief Title
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Official Title
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
October 31, 2028 (Anticipated)
Study Completion Date
October 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma, Carcinomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Given by IP (Intraperitoneal injection)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Given by IV (vein)
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl®
Intervention Description
Given by IV (vein)
Intervention Type
Drug
Intervention Name(s)
Famotidine
Other Intervention Name(s)
Pepcid®
Intervention Description
Given by IV (vein)
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-Yin Chang, RN
Phone
713-745-7335
Email
hchang@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Badgwell, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiu-Yin Chang, RN
Phone
713-745-7335
Email
hchang@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Brian Badgwell, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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