Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

NCT03330028 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2017-0232NCI-2018-01035
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease. This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC. The study doctor can describe how the study drugs and HIPEC are designed to work. Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Diseases of Oesophagus Stomach and Duodenum

Keywords

Diseases of oesophagus stomach and duodenum; Gastric cancer; Gastroesophageal cancer; Adenocarcinoma of the stomach or gastroesophageal junction; Hyperthermic intraperitoneal chemotherapy; HIPEC; Paclitaxel; Taxol; Dexamethasone; Decadron; Diphenhydramine; Benadryl; Cisplatin; Platinol-AQ; Platinol; CDDP; Mitomycin-C; Mitomycin; Famotidine; Pepcid

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

  MTD selected based on isotonic regression as specified per methods by Liu and Yuan.

  3 to 7 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion

• Dose Limiting Toxicity (DLT) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

  Dose limiting toxicity (DLT) graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) by organ system. DLT defined as any grade III/IV non-hematologic or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy.

  Within 21 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion

Study Arms (1)

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

EXPERIMENTAL

Participants receive heated Mitomycin, Cisplatin, and Paclitaxel as a liquid that is injected through 3 to 4 small incisions into the abdomen over about 1 hour.

Drug: Dexamethasone; Drug: Diphenhydramine; Drug: Famotidine; Drug: Mitomycin C; Drug: Cisplatin; Drug: Paclitaxel

Interventions

Dexamethasone DRUG

10 mg by vein approximately 60 minutes before Paclitaxel.

Also known as: Decadron

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

Diphenhydramine DRUG

50 mg by vein approximately 60 minutes before Paclitaxel.

Also known as: Benadryl

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

Famotidine DRUG

20 mg by vein approximately 60 minutes before Paclitaxel.

Also known as: Pepcid

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

Mitomycin C DRUG

Mitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

Also known as: Mitomycin

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

Cisplatin DRUG

Cisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

Also known as: Platinol-AQ, Platinol, CDDP

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)

Paclitaxel DRUG

Starting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen. Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2.

Also known as: Taxol

Hyperthermic Intraperitoneal Chemoperfusion (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/uL b. Absolute neutrophil count \>= 1,500/uL c. Platelets \>= 60,000/Ul d. Serum creatinine \<= 1.5 mg/dL
• Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
• Completion of preoperative systemic chemotherapy.

You may not qualify if:

• 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 Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Dexamethasone; Calcium Dobesilate; Diphenhydramine; Famotidine; Mitomycin; Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Ethylamines; Amines; Benzhydryl Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Brian D. Badgwell, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: October 27, 2017
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)