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

April 20, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Groups:

If participant is found to be eligible to take part in this study, participant will be assigned to a dose level of paclitaxel based on when participant joins this study. Up to 8 dose levels of paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel is found.

All participants will receive the same dose level of mitomycin and cisplatin.

HIPEC Treatment and Study Visits:

On the day of HIPEC treatment, participant will receive heated mitomycin, cisplatin, and paclitaxel as a liquid that is injected through 3 to 4 small incisions in participant's abdomen over about 1 hour. Heated mitomycin, cisplatin, and paclitaxel will be delivered through plastic tubing that is connected to a pump into the abdominal cavity. The pump pushes the heated drugs into the abdominal cavity and then pulls it out and recirculates the drugs. The skin of the abdominal cavity is temporarily closed during this procedure. A pump will be used to pump the heated drugs in and out of the abdominal cavity over 60 minutes while the surgeon gently presses on the abdominal wall so the drugs can reach all areas in the abdominal cavity. After 60 minutes, the drugs are removed and the abdominal cavity will be washed. The remaining fluid will be removed before the surgeon closes the abdominal cavity with stitches.

Additionally, participant will be given standard drugs to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.

Participant will remain in the hospital for 3-7 days after treatment.

While participant is in the hospital after surgery, blood (about 2-3 tablespoons) may be drawn for routine tests at any time that the study doctor thinks it is needed.

One (1) time between 2-6 weeks after HIPEC Treatment:

  • Participant will have a physical exam.
  • Blood (about 2-3 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

Participant will have routine clinic visits or participant will be called every 6 months after the HIPEC procedure. Participant will be asked about any other cancer treatments participant may be receiving. If participant is called, these calls should last about 5-10 minutes. If participant stopped the study early, the study doctor may ask participant to return to the clinic for extra CT scans, PET scan, or MRIs during the follow-up period.

Participant will have a CT scan, PET scan, or MRI of participant's chest, abdomen, and pelvis every 6 months for 5 years after surgery to check the status of the disease.

Length of Study Participation:

Participant will be on study for about 5 years after participant's last procedure (HIPEC or surgery). Participant will be taken off study early if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the follow-up visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 years and above. There will be no upper age restriction.
  2. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
  4. 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
  5. Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
  6. Completion of preoperative systemic chemotherapy.

Exclusion Criteria:

  1. Infections such as pneumonia or wound infections that would preclude protocol therapy.
  2. 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.
  3. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
  4. Subjects deemed unable to comply with study and/or follow-up procedures.
  5. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyperthermic Intraperitoneal Chemoperfusion (HIPEC)
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
10 mg by vein approximately 60 minutes before Paclitaxel.
Other Names:
  • Decadron
Drug: Diphenhydramine
50 mg by vein approximately 60 minutes before Paclitaxel.
Other Names:
  • Benadryl
Drug: Famotidine
20 mg by vein approximately 60 minutes before Paclitaxel.
Other Names:
  • Pepcid
Drug: Mitomycin C
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.
Other Names:
  • Mitomycin
Drug: Cisplatin
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.
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
Drug: Paclitaxel

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.

Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD) of Paclitaxel via Intraperitoneal Route Combined with Fixed Doses of Mitomycin and Cisplatin during Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Time Frame: 3 to 7 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
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)
Time Frame: Within 21 days after Hyperthermic Intraperitoneal Chemotherapy (HIPEC) infusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian D. Badgwell, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-0232
  • NCI-2018-01035 (Registry Identifier: NCI CTRP- Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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