High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

This study is ongoing, but not recruiting participants.

First Received: December 10, 1999 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Robert Roessle Comprehensive Cancer Center - Charite Campus Buch European Organization for Research and Treatment of Cancer Federation Francophone de Cancerologie Digestive Grupo Espanol Tratamiento Tumores Digestivos
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004150

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Condition	Intervention	Phase
Colorectal Cancer	Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid

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

Study Start Date:

March 1999

Detailed Description:

OBJECTIVES:

Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.
Compare the safety of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.

Patients are randomized to one of two treatment arms.

Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.
Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.

Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses. OR
Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses. Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon
Must have had curative radical resection within 56 days prior to study
- No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

WHO 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 10.0 g/dL

Hepatic:

Bilirubin no greater than 2.0 mg/dL

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No severe coronary heart disease
No New York Heart Association class III or IV heart failure

Other:

No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
No uncontrolled infection
No other severe disease
No known allergy to leucovorin calcium
No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis
No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)
Not pregnant or nursing
Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for colon cancer

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy for colon cancer

Surgery:

See Disease Characteristics

Other:

No other concurrent systemic anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004150

Show 85 Study Locations

Sponsors and Collaborators

Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

European Organization for Research and Treatment of Cancer

Federation Francophone de Cancerologie Digestive

Grupo Espanol Tratamiento Tumores Digestivos

Investigators

Investigator:	Claus-Henning Koehne, MD	Klinikum Oldenburg
Investigator:	G. Leam	Saint Laurentius Ziekenhuis
Investigator:	Laurent Bedenne, MD	Hopital Du Bocage
Study Chair:	Alfredo Carrato-Mena, MD	Hospital Universitario de Elche

More Information

Additional Information:

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

Publications:

Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.

Fensterer H, Radlwimmer B, Strater J, Buchholz M, Aust DE, Julie C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Kohne CH, Kestler HA, Schwaenen C, Nessling M, Lutz MP, Lichter P, Gress TM; EORTC Gastrointestinal (GI) Group. Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer. 2007 Apr 2;7:58.

Study ID Numbers:	CDR0000067383, PETACC-2, EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004150 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III colon cancer
adenocarcinoma of the colon
mucinous adenocarcinoma of the colon

Study placed in the following topic categories:

Antimetabolites
Vitamin B Complex
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Colonic Diseases
Adjuvants, Immunologic
Leucovorin
Trace Elements
Intestinal Diseases
Immunosuppressive Agents
Rectal Diseases

Intestinal Neoplasms
Folic Acid
Calcium, Dietary
Digestive System Diseases
Vitamins
Fluorouracil
Gastrointestinal Neoplasms
Micronutrients
Adenocarcinoma
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

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

Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009