Clinical trial · Interventional

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan

NCT00960544CI-TRIAL-00039078withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Principal Investigator departed from institution

Summary

Brief summary (as posted)

The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Capecitabine	Drug	Capecitabine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Capecitabine
description
Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
interventionNames
1. Drug: Capecitabine

Primary outcomes (1)

measure
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)
timeFrame
PK testing blood draw before first dose of capecitabine, and at 30, 60, and 90 minutes, then 2, 6, 8, and 10 hours after first dose.
description
Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients must have a pathologic or cytologic diagnosis of invasive carcinoma of the breast.
2. Patients must give informed consent for protocol participation.
3. Age \>/= 18 years
4. Patients must have and ECOG performance status of \</=2.
5. Patients must be scheduled to receive capecitabine using a BID dosing strategy administered on days 1-14 of a 21-day cycle.
6. Patients must agree to blood draws for PK/PD sampling.
7. Patients are allowed to receive cytotoxic therapy in combination with capecitabine.
8. Patients must not require concurrent radiation, or hormonal therapy while receiving protocol therapy
9. Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics as prophylaxis is allowed.
10. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. Both men and women should practice an effective method of birth control while receiving capecitabine.
11. Patients must have recovered to grade \<1 from all acute toxicity of previous chemotherapy, radiation or hormonal therapy and have adequate hematologic and hepatic function: Granulocyte count \>/= 1,500/mcL; Platelet count \>/= 100,000/mcL; Bilirubin \</= 1.5 x ULN; AST and/or ALT \</= 2 x ULN; Alkaline phosphatase (liver component, if fractionated) \</= 2 x ULN; Serum creatinine within normal limits.

Exclusion Criteria:

1. Untreated or uncontrolled brain metastasis
2. History of prior therapy with capecitabine
3. Patient inability to take or absorb oral medications

References

Publications (0)

Data not yet available

No reference posted for this study.