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A Prospective Random Assignment Trial to Study Operative Debulking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma

Phase 3
18 Years
Not Enrolling
Gastrointestinal Neoplasm

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Trial Information

A Prospective Random Assignment Trial to Study Operative Debulking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma

Patients with low-grade gastrointestinal adenocarcinoma and peritoneal carcinomatosis will
undergo laparotomy and tumor debulking. Patients will be randomized at completion of tumor
debulking to receive continuous hyperthermic peritoneal perfusion (HIPEC,formerly CHPP) with
250 mg/m^2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mg/m^2 and
paclitaxel 125 mg/m^2 once between postoperative day 7 and 12. All patients will receive
systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks
starting 4 to 6 weeks after operation and continuing for four cycles. The major endpoint is
time to intraperitoneal tumor progression and survival in patients stratified based on
history of previous treatment with systemic chemotherapy (yes vs. no), history of prior
debulking surgery; and ability to optimally vs. suboptimally debulk intraperitoneal tumor

Inclusion Criteria


1. The patient must have histologically or cytologically proven peritoneal
carcinomatosis from low-grade mucinous adenocarcinoma of the gastrointestinal
tract. Patients with no tissue for examination may undergo percutaneous needle
aspiration under computed tomography (CT) or ultrasound guidance as clinically
indicated or a laparotomy with biopsy if a tumor grade cannot be determined on
other available material.

2. Radiologic workup must demonstrate that there is no imageable disease outside of
the peritoneal cavity.

3. Radiologic workup or prior abdominal exploration must show abnormalities
consistent with disease which can be debulked to a residual size of less than 1
cm in diameter per tumor deposit in the judgement of the investigators.

4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
status of less than or equal to 2 on study entry and on the day prior to planned

5. Patients must have a minimum expected duration of survival of greater than 16

6. Patients must have recovered from any severe toxicity from all prior
chemotherapy, immunotherapy or radiotherapy except as outlined in appendix 1 of
the protocol and be at least 30 days past the date of their last treatment.

7. Patients must have a serum aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) within 5 times the upper limit of normal and a total
serum bilirubin of less than 3 times the upper limit of normal, both of which
define the upper limit of grade 2 treatment related toxicities..

8. Patients must have a absolute neutrophil count (ANC) greater than

9. Patients must be age greater than or equal to 18 years.


1. Patients will be excluded if they have concomitant medical problems that would place
them at unacceptable risk for a major surgical procedure.

1. Patients at increased risk for coronary artery disease or cardiac dysfunction
(e.g. age greater than 65, and a history of hypertension, first degree relative
with atherosclerotic coronary artery evaluation and will not be eligible if they
demonstrate significant irreversible ischemia on a stress thallium study or an
ejection fraction of less than 40%.

2. Patients who have shortness of breath with minimal exertion or who are at risk
for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function
testing and will not be eligible if their forced expiratory volume 1 (FEV1) is
less than 1.2 liters or their maximum voluntary ventilation is less than 50% of

2. Patients who have a neurological toxicity of Grade 3 or greater will be excluded
because of the potential neurotoxicity associated with platinum and paclitaxel

3. Patients will be ineligible if they have a serum creatinine of greater than 1.5 mg/dL
unless the measured creatinine clearance is greater than 60mL/min/1.73m^2.

4. Patients will be ineligible if platelets are less than 75, 000/mm^3.

5. Patients who have failed previous intraperitoneal chemotherapy will be ineligible.

6. Pregnant women or women who are breast-feeding will be ineligible.

7. Patients less than 30 kg will be ineligible.

8. Patients who have undergone two or more operative procedures to debulk disease, have
received 2 or more regimens of systemic chemotherapy, or any previous continuous
hyperthermic peritoneal perfusion (CHPP) therapy will be excluded from study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans.

Outcome Time Frame:


Safety Issue:



United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

September 2008

Related Keywords:

  • Gastrointestinal Neoplasm
  • Appendiceal Cancer
  • Regional Therapy
  • Carcinomatosis
  • Hyperthermia
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Carcinoma



National Cancer Institute (NCI) Bethesda, Maryland  20892