Standard Versus Continuous Capecitabine in Advanced Breast Cancer - Full Text View

Sponsor:	Hospital San Carlos, Madrid
Collaborator:	Hospital Juan Canalejo, La Coruña, Spain
Information provided by:	Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT00418028

Purpose

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. There are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks on, one week off)with a continuous administration schedule (800 mg/m2/12hr). The latter administer approximately the same cumulative dose of capecitabine as the standard schedule. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm).We assume similar antitumor activity in both arms.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: capecitabine	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:

time to progression [ Time Frame: 2005-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Time Frame: 2005-2009 ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 2005-2009 ] [ Designated as safety issue: Yes ]
Relation of patient polymorphisms to toxicity and activity [ Time Frame: 2005-2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	176
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental capecitabine 800 mg/m2 twice a day orally continuous administration	Drug: capecitabine 800 mg/m2 twice a day orally continuous
2: Active Comparator capecitabine 1250 mg/m2 twice a day x 14 days every 3 weeks	Drug: capecitabine 1250 mg/m2 twice a day orally x 14 days every 3 weeks

Detailed Description:

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. Some authors have tested continuous administration schedules of capecitabine, showing better tolerance and apparently similar antitumor activity. Capecitabine is a pro-drug of 5-FU and mimics an i.v. continuous infusion administration of this antimetabolite. On the other hand, there are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks on, one week off)with a continuous administration schule (800 mg/m2/12hr). The latter schedule administer approximately the same cumulative dose of capecitabine as the standard one. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). We assume similar antitumor activity in both arms.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic breast cancer
Prior anthracyclines and/or taxanes
ECOG>2
Measurable disease by RECIST
Age 18-75

Exclusion Criteria:

Known hypersensitivity or toxic reactions to fluoropyrimidines
Prior capecitabine therapy
Prior cardiac disease
Relevant renal nal insufficiency (creatinine clearance <30 ml/min)
Active infection
Second cancers
Impaired bone marrow, liver or cardiac function
More than two lines of chemotherapy for advanced disease.
Her2 amplification

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418028

Contacts

Contact: Miguel Martin, MD, PhD	+34-91-3303546	mmartin@geicam.org
Contact: Jose Angel Garcia Saenz, MD, PhD	+34-91-3303546	jagsaenz@yahoo.es

Locations

Spain
Hospital Clinico San Carlos	Recruiting
Madrid, Spain, 28040
Contact: Miguel Martin, MD,PhD +34-91-3303546 mmartin@geicam.org
Principal Investigator: Miguel Martin, MD,PhD

Sponsors and Collaborators

Hospital San Carlos, Madrid

Hospital Juan Canalejo, La Coruña, Spain

Investigators

Principal Investigator:

Miguel Martin, MD,PhD

Hospital Clinico San Carlos

More Information

No publications provided

Responsible Party:	Hospital San Carlos ( Miguel Martin, MD )
Study ID Numbers:	05/237
Study First Received:	January 3, 2007
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00418028 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Hospital San Carlos, Madrid:

capecitabine
schedule
breast cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Breast Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Fluorouracil
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009