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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00056108

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them in different ways may kill more tumor cells. It is not yet known whether surgery followed by chemotherapy is more effective with or without continuous hyperthermic peritoneal perfusion in treating peritoneal carcinomatosis.

PURPOSE: This randomized phase III trial is studying chemotherapy and continuous hyperthermic peritoneal perfusion after surgery to see how well they work compared to chemotherapy alone after surgery in treating patients with peritoneal carcinomatosis from gastrointestinal cancer.

Condition	Intervention	Phase
Carcinoma of the Appendix Peritoneal Cavity Cancer	Drug: FOLFOX regimen Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Fluorouracil Leucovorin Cisplatin Paclitaxel Citrovorum factor Oxaliplatin Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to peritoneal progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patterns of tumor progression [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	January 2006
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Compare the progression-free and overall survival of patients treated with these regimens.
Compare the quality of life of patients treated with these regimens.
Compare the patterns of failure in patients treated with these regimens.

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

More than 16 weeks

Hematopoietic

Absolute neutrophil count > 1,500/mm^3
Platelet count ≥ 75,000/mm^3

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

FEV_1 ≥ 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056108

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

James F. Pingpank, MD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000272076, NCI-03-C-0085
Study First Received:	March 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00056108 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

carcinoma of the appendix
pseudomyxoma peritonei

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Colonic Diseases
Leucovorin
Oxaliplatin
Neoplasms by Site
Cisplatin
Vitamins
Therapeutic Uses
Peritoneal Diseases

Micronutrients
Vitamin B Complex
Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators
Antimitotic Agents
Abdominal Neoplasms
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on November 27, 2009