Capecitabine Pharmacokinetics(PK)-Actual Versus Ideal Body Weight

Cycle 1 : Capecitabine 1,250 mg/m2 PO BID for 7 consecutive days (D1 - D7) will be
administered by subject (with Ideal Body Weight being used to determine BSA) for dosage. Day
8-No drug administered.

Capecitabine 1,250 mg/m2 PO BID for 7 more consecutive days (D9 - D15) will be administered
by subject (with Actual Body Weight being used to determine BSA) for dosage. There will be 6
consecutive days that no drug will be administered by subject (Days 16-21).

Cycle 2 and beyond: Capecitabine 1,250 mg/m2 PO BID for 14 consecutive days (D1 - D14) will
be administered by subject (with Actual Body Weight being used to determine BSA) for dosage.
Days 15-21-No drug administered.

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 (microliters), Hemoglobin > 8gm/dL
(transfusions permitted) and platelets > 75,000/mcL

Renal: serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance (CrCl)
(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 document.

- 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 (Prothrombin Time/International Normalized Ratio) 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
breastmilk.

- 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.