Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

NCT02092298 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0989NCI-2014-01105
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal cancer; Hyperthermic Intraperitoneal Chemoperfusion; HIPEC; Gastric carcinomatosis; Gastroesophageal cancer; Mitomycin C; Mitomycin; Cisplatin; Platinol-AQ; Platinol; CDDP; Sodium Thiosulfate; Tinver

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy

  Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

  Between the second and sixth week after treatment, up to 5 years

• Overall Survival (OS) From the First Laparoscopic HIPEC

  Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

  From the day of surgery, until the last day of follow up, until death, up to 5 years

Study Arms (1)

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

EXPERIMENTAL

Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.

Drug: Mitomycin C; Drug: Cisplatin; Drug: Sodium Thiosulfate

Interventions

Mitomycin C DRUG

Mitomycin C 30 mg delivered laparoscopically for 60 minutes.

Also known as: Mitomycin

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Cisplatin DRUG

Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.

Also known as: Platinol-AQ, Platinol, CDDP

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Sodium Thiosulfate DRUG

Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.

Also known as: Tinver

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above. There will be no upper age restriction.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
• Adequate renal, and bone marrow function: a. Leukocytes \>/= 3,000/microL; b. Absolute neutrophil count \>/= 1,500/microL; c. Platelets \>/= 100,000/Ul; d. Serum creatinine \</= 1.5 mg/dL.
• Hepatic function: AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN.
• Distant Metastatic Disease limited to peritoneum and radiologically occult (not visualized on preoperative imaging to include \[Computerized Tomography\] CT scan, Ultrasound, \[Magnetic Resonance Imaging\] MRI, PET/CT): a. Positive peritoneal cytology; b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
• Completion of preoperative systemic chemotherapy.

You may not qualify if:

• Distant metastatic disease not limited to peritoneum: a. Solid organ metastases (liver, central nervous system, lung).
• Any distant metastatic disease visualized on preoperative imaging: a. Solid organ metastases; b. Clear radiologic evidence of carcinomatosis.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Badgwell B, Blum M, Das P, Estrella J, Wang X, Fournier K, Royal R, Mansfield P, Ajani J. Lessons learned from a phase II clinical trial of laparoscopic HIPEC for gastric cancer. Surg Endosc. 2018 Jan;32(1):512. doi: 10.1007/s00464-017-5668-9. Epub 2017 Jun 22.

  PMID: 28643069 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Mitomycin; Cisplatin; sodium thiosulfate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Brian Badgwell,Professor, Surgical Oncology
• Organization: UT MD Anderson Cancer Center

csentonn@mdanderson.org

713-745-3715

Study Officials

• Brian D. Badgwell, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: May 8, 2014
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (1)