A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer
Inclusion Criteria:
1. Histologically or cytologically confirmed esophageal cancer with histology of
squamous carcinoma or adenocarcinoma
2. Clinically diagnosed metastatic or recurrent esophageal cancer according to Sixth
Edition of the AJCC Cancer Staging Manual (Appendix V)
3. At least 18 years old
4. Disease status must be that of measurable disease defined as RECIST:Lesions that can
be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral CT
scan or physical examination
5. ECOG performance status 0-2
6. No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest
radiotherapy for the primary lesion is allowed
7. Adequate major organ function including the following:Hematologic function: WBC ≥
3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥
100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal
function: serum creatinine ≤ 1.5mg/dL
8. Patients should sign an informed consent
9. If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
device [IUD], birth control pills, or barrier device) during and for 3 months after
trial. If male, use of an approved contraceptive method during the study and 3 months
afterwards. Females with childbearing potential must have a urine negative hCG test
within 7 days prior to the study enrollment.
Exclusion Criteria:
1. MI within preceding 6 months or symptomatic heart disease including unstable angina,
congestive heart failure, or uncontrolled arrhythmia
2. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complication of study therapy
3. Pregnant or nursing women
4. Other malignancy with the past 5 years except adequately treated cutaneous basal cell
carcinoma or uterine cervix in situ cancer
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks