A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine). - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00661102

Purpose

This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: capecitabine [Xeloda] Drug: dexpantenol [Bepantol] Drug: Corticosteroids Drug: Placebo	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Foot Health

Drug Information available for: Capecitabine Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-Foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hand-foot syndrome onset [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
QoL C-30 score [ Time Frame: Weeks 7, 13 and 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] As prescribed Drug: dexpantenol [Bepantol] As prescribed
2: Active Comparator	Drug: capecitabine [Xeloda] As prescribed Drug: Corticosteroids As prescribed
3: Placebo Comparator	Drug: capecitabine [Xeloda] As prescribed Drug: Placebo As prescribed

Eligibility

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

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
breast cancer or colorectal cancer patients;
treated with oral Xeloda for <=5 days;
lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).

Exclusion Criteria:

existence of clinical symptoms suggesting hand-foot syndrome;
use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
diabetes mellitus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661102

Contacts

Contact: Please reference Study ID Number: ML21419	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Brazil
	Not yet recruiting
PORTO ALEGRE, Brazil, 90610-000
	Not yet recruiting
Sao Paulo, Brazil, 01221-020
	Not yet recruiting
SAO PAULO, Brazil, 04023-061
	Not yet recruiting
BELO HORIZONTE, Brazil, 31130-110
	Not yet recruiting
SAO PAULO, Brazil, 04023-900
	Not yet recruiting
SOROCABA, Brazil, 18030-510
	Not yet recruiting
SANTOS, Brazil, 11075-350
	Not yet recruiting
SALVADOR, Brazil, 40170-070
	Not yet recruiting
SAO PAULO, Brazil, 01401-901
	Not yet recruiting
SANTO ANDRE, Brazil, 09060-650
	Not yet recruiting
IJUÍ, Brazil, 98700-000
	Not yet recruiting
PORTO ALEGRE, Brazil, 90020-090
	Not yet recruiting
BELO HORIZONTE, Brazil, 30380-490
	Not yet recruiting
JAÚ, Brazil, 17210-080
	Not yet recruiting
SAO PAULO, Brazil, 04039-901
	Not yet recruiting
RIO DE JANEIRO, Brazil, 22745-130
	Not yet recruiting
FORTALEZA, Brazil, 60336-550
	Not yet recruiting
NATAL, Brazil, 59062-000
	Not yet recruiting
FLORIANOPOLIS, Brazil, 88020-200
	Not yet recruiting
SÃO JOSÉ DO RIO PRETO, Brazil, 15090-000
	Not yet recruiting
PORTO ALEGRE, Brazil, 90035-003
	Recruiting
LAJEADO, Brazil, 95900-000
	Not yet recruiting
RIO DE JANEIRO, Brazil, 21020-130
	Not yet recruiting
CAXIAS DO SUL, Brazil, 95070-560
	Not yet recruiting
TERESINA, Brazil, 64001-280
	Not yet recruiting
FORTALEZA, Brazil, 60741-420
	Not yet recruiting
CAMPINAS, Brazil, 13083-970
	Not yet recruiting
SANTOS, Brazil, 11075-900
	Not yet recruiting
NITEROI, Brazil, 24303-900
	Not yet recruiting
PORTO ALEGRE, Brazil, 91430-001
	Not yet recruiting
PETRÓPOLIS, Brazil, 25625-070
	Not yet recruiting
GOIANIA, Brazil, 74605-020
	Not yet recruiting
RIBEIRÃO PRETO, Brazil, 14048-900
	Not yet recruiting
GOIANIA, Brazil, 74605-070
	Not yet recruiting
ITAJAÍ, Brazil, 88301-220
	Not yet recruiting
TAGUATINGA, Brazil, 72115-700
	Not yet recruiting
SALVADOR, Brazil, 41810-570
	Not yet recruiting
CAXIAS DO SUL, Brazil, 95020-170
	Not yet recruiting
SAO PAULO, Brazil, 14784-400

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21419
Study First Received:	April 16, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00661102
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Breast Neoplasms
Breast Diseases
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009