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
Recruitment status was Recruiting
Sponsor:
Centre Antoine Lacassagne
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: capecitabine Other: laboratory biomarker analysis Other: pharmacological study |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953537
Locations
| France | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Jean Marc Ferrero, MD 33-4-9203-1114 jean-marc.ferrerero@nice.fnclcc.fr | |
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
| Principal Investigator: | Jean Marc Ferrero, MD | Centre Antoine Lacassagne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00953537 History of Changes |
| Other Study ID Numbers: | CDR0000638377, CALACASS-DPD-Sein, 2008/21, INCA-RECF0942, EUDRACT-2008-004136-20 |
| Study First Received: | August 5, 2009 |
| Last Updated: | August 5, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Dihydrouracil Dehydrogenase (NADP) Fluorouracil Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013