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

Phase 2

Completed

• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Peritoneal Carcinomatosis
• Interventions: Drug: Cisplatin; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Mitomycin

• Registration Number: NCT02891447
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Status Verified: 2023-04
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (mitomycin, cisplatin)	Hyperthermic Intraperitoneal Chemotherapy	Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
Treatment (mitomycin, cisplatin)	Cisplatin	Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
Treatment (mitomycin, cisplatin)	Mitomycin	Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Date of diagnosis to date of death or last follow-up	Overall survival from the date of diagnosis in subjects with stage IV gastric cancer

Secondary Outcome Measures

Name	Time	Method
Clavien-Dindo Surgical Complications	90-days from surgery	90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.; Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States