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Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

Primary Purpose

Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage IV Gastric Cancer AJCC v8

Eligibility Criteria

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

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Safety data will be summarized using frequency tables by grade and attribution.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2020
Last Updated
February 14, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04220827
Brief Title
Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer
Official Title
A Phase I Study of Intraperitoneal Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Pathologic Stage IV Gastric Cancer AJCC v8, Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Peritoneal Carcinomatosis, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IP
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Safety data will be summarized using frequency tables by grade and attribution.
Time Frame
Up to after 30 days after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian D Badgwell
Phone
713-792-6940
Email
bbadgwell@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Badgwell
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
Brian D. Badgwell
Phone
713-792-6940
Email
bbadgwell@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Brian D. Badgwell

12. IPD Sharing Statement

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

Learn more about this trial

Paclitaxel for the Treatment of Gastric or Gastroesophageal Cancer

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