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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-04-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Peritoneal Carcinomatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (mitomycin, cisplatin)

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

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given intraperitoneally

Hyperthermic Intraperitoneal Chemotherapy

Intervention Type DRUG

Undergo HIPEC

Mitomycin

Intervention Type DRUG

Given intraperitoneally

Interventions

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Cisplatin

Given intraperitoneally

Intervention Type DRUG

Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

Intervention Type DRUG

Mitomycin

Given intraperitoneally

Intervention Type DRUG

Other Intervention Names

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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 HIPEC Ametycine MITO MITO-C Mito-Medac Mitocin Mitocin-C Mitolem Mitomycin C Mitomycin-C Mitomycin-X Mitomycine C Mitosol Mitozytrex Mutamycin Mutamycine NCI-C04706

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No