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Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

Primary Purpose

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Hyperthermic Intraperitoneal Chemotherapy
Mitomycin
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:

  • 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 may be visualized on imaging:

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

Exclusion Criteria:

  • Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, 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 have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) 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
  • 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (mitomycin, cisplatin)

Arm Description

Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

Outcomes

Primary Outcome Measures

Overall survival
Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
Patterns of tumor recurrence
Will be assessed by reviewing routine surveillance imaging.

Secondary Outcome Measures

Overall survival
Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.

Full Information

First Posted
September 1, 2016
Last Updated
April 12, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02891447
Brief Title
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
Official Title
A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)

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 II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, 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. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration. SECONDARY OBJECTIVES: I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis. OUTLINE: Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy. After completion of study treatment, patients are followed up within 4 weeks, and then 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
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal 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
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (mitomycin, cisplatin)
Arm Type
Experimental
Arm Description
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Intervention Description
Given intraperitoneally
Intervention Type
Drug
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy
Other Intervention Name(s)
HIPEC
Intervention Description
Undergo HIPEC
Intervention Type
Drug
Intervention Name(s)
Mitomycin
Other Intervention Name(s)
Ametycine, MITO, MITO-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706
Intervention Description
Given intraperitoneally
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
Time Frame
From the time of diagnosis of stage IV disease up to 5 years
Title
Patterns of tumor recurrence
Description
Will be assessed by reviewing routine surveillance imaging.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups.
Time Frame
From the time of surgery up to 5 years

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 may be visualized on imaging: Positive peritoneal cytology Carcinomatosis on diagnostic laparoscopy or laparotomy Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC Exclusion Criteria: Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, 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 have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) 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 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
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
32556731
Citation
Badgwell B, Ikoma N, Murphy MB, Wang X, Estrella J, Roy-Chowdhuri S, Das P, Minsky BD, Lano E, Song S, Mansfield P, Ajani J. A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology. Ann Surg Oncol. 2021 Jan;28(1):258-264. doi: 10.1245/s10434-020-08739-5. Epub 2020 Jun 17.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

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Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

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