Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Surgery Followed By Chemotherapy With or Without Intraperitoneal Chemotherapy in Treating Patients With Peritoneal Carcinomatosis From Gastrointestinal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	NCI-03-C-0085 NCT00056108

Special Category: NCI Web site featured trial

Objectives

1. Compare time to intraperitoneal tumor progression after laparotomy and tumor debulking with vs without continuous hyperthermic peritoneal perfusion in patients with peritoneal carcinomatosis from low-grade gastrointestinal adenocarcinoma.
2. Compare the progression-free and overall survival of patients treated with these regimens.
3. Compare the quality of life of patients treated with these regimens.
4. Compare the patterns of failure in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed peritoneal carcinomatosis from low-grade mucinous adenocarcinoma of the gastrointestinal tract



• No imageable disease outside of the peritoneal cavity by radiological workup



• Presence of abnormalities consistent with disease that can be debulked to a residual size of less than 1 cm in diameter per tumor deposit, as shown on radiologic workup or prior abdominal exploration

Prior/Concurrent Therapy:

Biologic therapy

• At least 30 days since prior immunotherapy and recovered

Chemotherapy

• At least 30 days since prior chemotherapy and recovered
• No prior intraperitoneal chemotherapy failure
• No more than 1 prior systemic chemotherapy regimen

Endocrine therapy

• Not specified

Radiotherapy

• At least 30 days since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• No more than 1 prior operative procedure to debulk disease

Other

• No prior continuous hyperthermic peritoneal perfusion

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 16 weeks

Hematopoietic

• Absolute neutrophil count > 1,500/mm³
• Platelet count ≥ 75,000/mm³

Hepatic

• Bilirubin < 3 times upper limit of normal (ULN)
• AST and ALT ≤ 5 times ULN

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance > 60 mL/min

Cardiovascular

• No significant irreversible ischemia on a stress thallium study*

  OR

• Ejection fraction ≥ 40%*

   [Note: *Only for patients at increased risk for coronary artery disease or cardiac dysfunction]

Pulmonary

• FEV₁ ≥ 1.2 liters*

  OR

• Maximum voluntary ventilation ≥ 50% of expected*

   [Note: *Only for patients with shortness of breath with minimal exertion or for those who are at increased risk for pulmonary disease]

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Weight ≥ 66 pounds (30 kg)
• No other concurrent medical problems that would place patient at an unacceptable risk for a major surgical procedure
• No grade 3 or greater neurological toxicity

Expected Enrollment

A total of 82 patients (41 per treatment arm) will be accrued for this study within 48 months.

Outcomes

Time to peritoneal progression

Patterns of tumor progression
Overall survival

Outline

This is a randomized study. Patients are stratified according to prior systemic chemotherapy (yes vs no), prior debulking surgery (yes vs no), and ability to debulk tumor (optimal vs sub-optimal debulking).

Patients undergo cytoreductive surgery and at the end of the debulking procedure are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin over 90 minutes. Patients have a peritoneal dialysis catheter inserted at the end of the procedure in order to receive paclitaxel and fluorouracil postoperatively (once between days 7 and 12).



• Arm II: Patients receive no CHPP or postoperative intraperitoneal chemotherapy.

Approximately 4-6 weeks after surgery, all patients receive systemic chemotherapy with oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours on days 1, 2, 15, and 16. Patients also receive fluorouracil IV over 15-30 minutes followed by fluorouracil IV continuously over 22 hours beginning on days 1, 2, 15, and 16. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline; 6 weeks postoperatively; after every other course of systemic chemotherapy; and then every 3 months for 2 years, every 4 months for 2 years, and then every 6 months thereafter.

Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months until 5 years from treatment date (surgery) or evidence of intraperitoneal tumor progression.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

James Pingpank, MD, Protocol chair		Ph: 301-402-2575 Email: pingpanj@mail.nih.gov

Related Information

Featured trial article

Registry Information
Official Title		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
Trial Start Date		2006-01-06
Trial Completion Date		2008-09-17
Registered in ClinicalTrials.gov		NCT00056108
Date Submitted to PDQ		2003-01-31
Information Last Verified		2006-12-03

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