Phase 2 N=20 Treatment

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

Gastric Adenocarcinoma · Gastroesophageal Junction Adenocarcinoma · Peritoneal Carcinomatosis

Bottom Line

View on ClinicalTrials.gov: NCT02891447 ↗

Enrolled (actual)

Serious AEs

35.0%

Results posted

Sep 2024

Primary outcome: Primary: Overall Survival — 22.1 Months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cisplatin (Drug); Hyperthermic Intraperitoneal Chemotherapy (Drug); Mitomycin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	22.1	—
SECONDARY Clavien-Dindo Surgical Complications	15; 6; 1	—

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.

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status = = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02891447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.