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Standard Versus Continuous Capecitabine in Advanced Breast Cancer
This study is currently recruiting participants.
Verified by Hospital San Carlos, Madrid, May 2008
First Received: January 3, 2007   Last Updated: May 14, 2008   History of Changes
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:


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