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Pilot Study Evaluating Pharmacokinetic Parameters of Capecitabine Dosing in Patients With Advanced Cancer and Elevated Body Mass Index

Phase 4
18 Years
Not Enrolling
Advanced Solid Tumors, Obesity

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Trial Information

Pilot Study Evaluating Pharmacokinetic Parameters of Capecitabine Dosing in Patients With Advanced Cancer and Elevated Body Mass Index

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced or metastatic
cancer for which capecitabine treatment is considered a standard treatment option.

- Patients with measurable or evaluable disease are eligible

- Patient's Body Mass Index must be 30 kg/m2 or higher.

- Eastern Cooperative Oncology Group performance status 0-2.

- Age >18 years.

- Life expectancy of greater than 12 weeks.

- Patients must have adequate organ and marrow function as defined below:

Hematologic: Absolute Neutrophil Count (ANC) >1000/mcL, Hemoglobin > 8gm/dL (transfusions
permitted)and platelets > 75,000/mcL

Renal: serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance (either
estimated or calculated) >60 mL/min/1.73 m for patients with creatinine levels above
institutional normal.

Females: Crcl =(140-age)(weight in kg)(0.85)/72 x Serum creatinine

Males: Crcl =(140-age)(weight in kg)/72 x Serum creatinine

Hepatic: Serum Bilirubin ≤ 1.5x ULN and No liver metastases: Aspartate
aminotransferase(AST)and Alanine transaminase(ALT) ≤ 2.5x ULN Liver metastases: AST and
ALT ≤ 5x ULN

- Ability to understand and the willingness to sign a written informed consent

- Capecitabine is contra-indicated in pregnant women because of known detrimental
effects on the fetus. A negative pregnancy test is required in all premenopausal
women within 14 days of study therapy initiation. Women of child-bearing potential
and men with an active female sexual partner must agree to use adequate contraception
(hormonal, surgical, barrier methods or abstinence allowed) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

Exclusion Criteria:

- Patients who have had systemic chemotherapies or targeted therapies within 3 weeks or
radiotherapy within 2 weeks prior to entering the study or those patients whose
adverse events from prior therapies have not recovered to < grade 1 and are still
considered clinically significant.

- Patients receiving any other investigational agents for cancer treatment.

- Patients with treated, stable brain metastases are allowed to enroll. Patients must
be at least 4 weeks from brain radiation and off any medications used to treat brain
metastases including steroids. Patients are allowed to be on anti-epileptic
medications that are not contraindicated based on the drug-interaction table.

- Patients with any condition of the gastrointestinal tract that is expected to result
in an inability to swallow or absorb oral medications (ie. prior surgical procedures
affecting absorption and requiring i.v. alimentation). This will be determined at
the discretion of the PI.

- Patients may not be taking any concomitant drugs that are contraindicated based on
the drug-interaction table.

- Concurrent treatment with warfarin (coumadin) is allowed, but close monitoring of the
PT/INR is recommended.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
severe infection, symptomatic congestive heart failure, unstable angina pectoris,
clinically significant or symptomatic cardiac arrhythmia, other malignancies
requiring therapy or psychiatric illness/social situations that would limit
compliance with study requirements.

- Pregnant women or women who are breastfeeding are excluded from this study because
capecitabine is a pregnancy category D drug and is known to pass to the infant in

- Patients with known deficiency of the dihydropyrimidine dehydrogenase (DPD) enzyme.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to capecitabine.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Comparison of Area Under Curve (AUC) and Cmax between full weight and limited based dosing (non-linear mixed effects modeling approach)

Outcome Description:

PK parameters will be summarized it terms of number of observations, means, standard deviations, medians, and ranges, stratified by time point. AUC will be estimated using the Lagrange approximation method and a paired t-test will be used to compare the PK parameters between full weight and limited weight based dosing.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Kari B. Wisinski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Data and Safety Monitoring Board

Study ID:

OS 12903



Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Advanced Solid Tumors
  • Obesity
  • Capecitabine pharmacokinetics PK
  • Elevated Body Mass Index (BMI)
  • Advanced Solid Tumors
  • Obesity



University of Wisconsin-Carbone Cancer Center Madison, Wisconsin  53705