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



Status:Recruiting
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:October 27, 2017
End Date:April 2022
Contact:Brian D. Badgwell, MD
Email:bbadgwell@mdanderson.org
Phone:713-792-6940

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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 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.

Inclusion Criteria:

1. Age 18 years and above. There will be no upper age restriction.

2. Eastern Cooperative Oncology Group (ECOG) performance status
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.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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