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A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer

Paclitaxel-80 mg/m2/IV D1 & D8 q 3 weeks Capecitabine-900 mg/m2/PO twice daily Days 1-14 q 3

Patients receive treatment every 3 weeks till disease progression.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate

Outcome Time Frame:

the ratio between the number of responders and number of patients assessable for tumor response

Safety Issue:


Principal Investigator

Heung Tae Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

June 2006

Completion Date:

December 2010

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer
  • Phase II
  • Metastatic esophageal cancer
  • Recurrent esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms