Mesothelioma Clinical Trials
Treatment of
Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and
Chemotherapy
This study is currently
recruiting patients.
For more information:National
Cancer Institute (NCI)
This study will test the effectiveness of an experimental
treatment for peritoneal cancer involving surgical removal of
the tumor, perfusion of the abdomen during surgery with a
heated solution of the drug cisplatin, and post-surgery
combination chemotherapy.
Patients with peritoneal cancer whose tumor is confined to
the abdomen may be eligible for this study. Candidates will be
screened with a medical history and physical examination
including blood tests, electrocardiogram, and possibly bone
scan, brain magnetic resonance imaging, and chest, abdomen and
pelvic CT scans. Those enrolled in the study will undergo
surgery to remove as much tumor as possible. Part of the
intestines, pancreas, stomach or the entire spleen may also be
removed if they are affected. During surgery, after the tumor
has been removed, two catheters (thin plastic tubes) will be
placed in the abdomen. A chemotherapy solution containing the
anti-cancer drug cisplatin heated to a temperature of about
108.6 degrees (10 degrees above normal body temperature) will
then be delivered into the abdomen through one catheter and
drained through another. After 90 minutes of bathing the
abdomen with this solution, the drug will be rinsed from the
abdomen and the catheters removed. Another small catheter will
then be placed and left inside the abdomen with one end coming
out through the skin. Two to 10 days after the operation, the
drugs fluorouracil (5-FU) and paclitaxel will be given through
this catheter.
After complete recovery from the surgery, the catheter will
be removed and the patient discharged from the hospital.
Clinic visits will be scheduled for periodic follow-up
examination and tests.
Patients in this study will also be asked to assess how
this therapy affects their general health and well being. This
will require filling out two quality-of-life questionnaires
before surgery and again at each follow-up visit after
surgery. Each questionnaire takes about 15 minutes to
complete.
Condition
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Treatment or
Intervention |
Abdominal Neoplasm Colonic
Neoplasm Mesothelioma Peritoneal Neoplasm |
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This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional Study
Design: Treatment
Official Title: Phase II Trial of
Continuous Hyperthermic Peritoneal Perfusion (CHPP) with
Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel
and 5-Fluorouracil for Peritoneal Carcinomatosis
Further Study Details:
Cytoreductive surgery plus aggressive combination
intraperitoneal chemotherapy may significantly alter the
natural history of peritoneal carcinomatosis. The purpose of
this study is to examine the treatment results of continuous
hyperthermic peritoneal perfusion with cisplatin plus early
postoperative intraperitoneal dwell therapy with 5-FU and
paclitaxel after cytoreductive surgery for peritoneal
carcinomatosis. Results will be assessed by following the time
to radiographic or clinical recurrence of disease and
survival. Patients will be stratified for entry based on
histology. This will include 3 cohorts: 1) peritoneal
mesothelioma; 2) low grade mucinous adenocarcinoma (including
low grade mucinous neoplasms of borderline malignant
potential); and 3) adenocarcinoma of gastrointestinal origin
(other than low grade mucinous).
Genders Eligible for Study: Both
INCLUSION CRITERIA: The patient must
have histologically proven peritoneal carcinomatosis from the
following histologies: primary peritoneal mesothelioma; low
grade mucinous adenocarcinoma (including low grade mucinous
neoplasms of borderline malignant potential); adenocarcinoma
of gastrointestinal tract origin (other than low grade
mucinous, excluding pancreatic cancer). Radiologic workup
must demonstrate that the disease is confined to the
peritoneal cavity. Radiologic workup or prior abdominal
exploration must be consistent with disease which can be
debulked to a residual size of less that 1 cm in diameter per
tumor deposit. Patients must have an ECOG performance
status of less than or equal to 2. Patients must have a
minimum expected duration of survival of greater than 8
weeks. Patients must have recovered from any toxicity from
all prior chemotherapy, immunotherapy or radiotherapy and be
at least 30 days past the date of their last
treatment.
EXCLUSION CRITERIA: Patients will be
excluded if they have concomitant medical problems that would
place them at unacceptable risk for a major surgical
procedure. Patients at increased risk for coronary artery
disease or cardiac dysfunction (e.g., age greater than 65,
history of hypertension, first degree relative with
atherosclerotic coronary artery disease) will undergo cardiac
evaluation and will not be eligible if they demonstrate
significant irreversible ischemia on a stress thallium study
or an injection fraction of less than 40%. Patients who
have shortness of breath with minimal exertion and who are at
risk for pulmonary disease (e.g., chronic smokers) will
undergo pulmonary function testing and will not be eligible if
their FEV1 is less than 1.2 liters or their maximum voluntary
ventilation is less than 50% of expected. Patients who have
a baseline neurological toxicity of Grade 3 or greater will be
excluded because of the potential neurotoxicity associated
with platinum and paclitaxel therapy. Patients will be
ineligible if they have a creatinine of greater than 1.5 or a
creatinine clearance of less 70 mL/min. Patients will be
ineligible if the WBC is less than 3000/microliters or
platelets are less than 75,000/mm(3). Patients will be
ineligible if the serum total bilirubin level or liver enzymes
are greater than 2 times the upper limit of
normal. Patients who have failed previous intraperitoneal
platinum therapy will be ineligible. Treatment failure is
defined as radiographic evidence of disease progression on two
consecutive CT scans within 6 months of treatment. Pregnant
women or women who are breast feeding will be
ineligible. Patients less than 30 kg will be
ineligible.
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