Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00953537

First received: August 5, 2009

Last updated: NA

Last verified: August 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 5, 2009

Last Updated Date

August 5, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

Official Title ^ICMJE

Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients

Brief Summary

RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.

PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

To determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (UH_2/U) ratio measured before starting treatment on grade 3-4 capecitabine-related toxicity in women with metastatic breast cancer.

Secondary

To prospectively test the value of the germinal genotype of thymidylate synthase (TS) and methylenetetrahydrofolate reductase (MTHFR) as predictors of resistance to capecitabine.
To evaluate the practical feasibility of such pre-therapeutic screening.
To determine the sensitivity, specificity, and positive and negative predictive values of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related toxicity in the first and second courses.
To evaluate the predictive gain provided by genotyping relative to phenotyping alone.
To evaluate the influence of TS and MTHFR gene polymorphisms on clinical response and duration of response.
To evaluate the pharmacokinetics of capecitabine and its metabolites and their relationship with UH_2/U and genotype.
To evaluate the total cost of pre-therapeutic phenotyping alone and the combination of phenotyping and genotyping.
To exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (DPYD) gene in patients who developed toxicity.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected 8-15 days before the start of treatment and periodically on the first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil ratio and high performance liquid chromatography analysis), genotyping (4 most relevant single nucleotide polymorphisms), and pharmacokinetic analysis.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: capecitabine
Other: laboratory biomarker analysis
Other: pharmacological study

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Completion Date

Not Provided

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Radiologically (by scintography) or histologically confirmed metastatic breast cancer
At least 1 measurable or evaluable target lesion
Receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
No uncontrolled brain metastases
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
Life expectancy ≥ 3 months
Fertile patients must use effective contraception
No chronic uncontrolled illness
No congestive heart failure
No peripheral venous disease
No severe uncontrolled infection
No hypoxemic respiratory failure
No prior primary cancer except for basal cell carcinoma of the skin
No psychologic disorder

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No capecitabine co-administered with chemotherapy

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00953537

Other Study ID Numbers ^ICMJE

CDR0000638377, CALACASS-DPD-Sein, 2008/21, INCA-RECF0942, EUDRACT-2008-004136-20

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Centre Antoine Lacassagne

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean Marc Ferrero, MD

Centre Antoine Lacassagne

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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