Patients Preference for Oral or i.v. Therapy - Full Text View

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00212589

Purpose

Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the standard chemotherapy for patients with colorectal cancer. Several studies have shown that Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes) bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In randomized studies efficacy is comparable to other FU/FA regimens.

It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy.

In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference.

Condition	Intervention	Phase
Colorectal Cancer	Drug: Capecitabine Drug: Fluorouracil + folinic acid	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Official Title:	A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer

Further study details as provided by Odense University Hospital:

Estimated Enrollment:	60
Study Start Date:	December 2002
Estimated Study Completion Date:	April 2004

Eligibility

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

Criteria

Inclusion Criteria:

Indication for treatment with a FU-regime
WHO Performance Status 0-1
Life expectancy > 3 months
Adequate haematological, renal and hepatic functions
Adequate contraceptives
Written informed consent

Exclusion Criteria:

Known CNS-metastases
Prior treatment with chemotherapy
Pregnant or breast feeding women
Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis
other serious illness or medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212589

Locations

Denmark
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Department of Oncology, Sonderborg Hospital
Sonderborg, Denmark, 6400
Department of Oncology, Esbjerg Hospital
Esbjerg, Denmark, 6700
Department of Oncology, Vejle Hospital
Vejle, Denmark, 7100

Sponsors and Collaborators

Odense University Hospital

Investigators

Principal Investigator:

Per Pfeiffer, MD

Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark

More Information

Publications:

Lima AP, del Giglio A. Randomized crossover trial of intravenous 5-FU versus oral UFT both modulated by leucovorin: a one-centre experience. Eur J Cancer Care (Engl). 2005 May;14(2):151-4.

Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Greim G, Peters GJ, van der Born K, Wanders J, de Boer RF, Martin C, Fumoleau P. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer. 2002 Feb;38(3):349-58.

Study ID Numbers:	11.02
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00212589
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

Patients preference
Colorectal cancer
Capecitabine
Fluorouracil + folinic acid
Cross-over study

Study placed in the following topic categories:

Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases

Leucovorin
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009