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A Phase I Study of Capecitabine In Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

A Phase I Study of Capecitabine In Patients With Solid Tumors

Inclusion Criteria:

1. Cytologically or histologically confirmed advanced or metastatic non- hematologic
malignancy that had failed previous therapies or cancer for which there are no
standard treatment options.

2. Presence of at least one uni-dimensional measurable lesion as defined by the RECIST

3. Required genotype characteristics:

- Group 1: TSER genotype 2R/2R or 2R/3R

- Group 2: TSER genotype 3R/3R

4. Able to swallow capsules

5. Age>=18 years

6. Kanorfsky performance status of at least 70% or ECOG performance status <2 (Appendix

7. Life expectancy of at least 3 months

8. Hb >=9 g/dL

9. ANC >=1.5 x 10^9/L

10. Platelet count >=100 x 10^9/L.

11. Total bilirubin and serum creatinine <=1.5x upper limits of normal reference range

12. Alkaline phosphatase, AST/ALT levels <=2.5x upper limit of normal. If hepatic
metastases are present, these parameters could be <=10x the ULN.

13. Women of reproductive age and men must agree to practice effective contraception
during the entire study period. Postmenopausal women must have been amenorrheic for
at least 12 months to be considered of non-child- bearing potential. Females with
childbearing potential must have a negative serum pregnancy test within 7days prior
to study enrolment. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.

14. Signed written informed consent

Exclusion Criteria:

1. Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy,
hormonal, biologic or any investigational therapy within 28 days prior to study drug
administration (6 weeks for mitomycin or nitroureas) and not recovered.

2. Patients who have not recovered from major surgery

3. Any woman pregnant or lactating.

4. Known CNS metastases

5. Renal impairment with a creatinine clearance <=50mL/min (as calculated according to
Cockcroft and Gault formula) or serum creatinine > ULN

6. Clinically significant cardiac disease, eg. Congestive cardiac failure, symptomatic
coronary heart disease, cardiac arrhythmia or myocardial infarction within the last
12 months.

7. Known HIV infection

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, other serious uncontrolled concomitant disease, psychiatric illness/
social situation that would limit study compliance.

9. Known allergies to any component of the study drug

10. Lack of physical integrity of the upper gastrointestinal tract or those with
malabsorption syndrome

11. Organ allografts

12. Known dihydropyrimidine dehydrogenase deficiency

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks followed by one week rest period (intermittent schedule) in patients with the advanced/ and or metastatic cancer based on TYMS genotype.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Ross Andrew Soo, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

May 2007

Completion Date:

May 2012

Related Keywords:

  • Solid Tumors
  • Neoplasms