A Phase I/II Trial of Epirubicin, Carboplatin & Capecitabine in Adult Cancer Patients
- Determine the maximum tolerated dose and the recommended phase II dose of capecitabine
administered with epirubicin and carboplatin in patients with unresectable locally
advanced, metastatic, or recurrent solid tumors.
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics (PK) of capecitabine and correlate these PK parameters
with clinical toxicity of this regimen in these patients.
- Correlate end-of-infusion levels of epirubicin and its metabolites with epirubicin dose
and clinical toxicity of this regimen in these patients.
- Determine the possible correlation between polymorphisms in the promoter region of the
thymidylate synthase gene with clinical toxicity of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive epirubicin IV over 2 hours and carboplatin IV over 30 minutes on day 1 and
oral capecitabine twice daily on days 2-5, 8-12, and 15-19. Courses repeat every 4 weeks in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional
patients are treated at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-45 patients (24 patients for phase II) will be accrued for
this study within 2 years.
Primary Purpose: Treatment
Brian P. Monahan, MD, FACP
National Cancer Institute (NCI)
United States: Federal Government
|Naval Medical Center, Portsmouth||Portsmouth, Virginia 23708-2197|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Research||Bethesda, Maryland 20892|