A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer
The primary objective of this study is to find out the response rate of twice weekly
paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma
patients who need palliative Chemotherapy. The secondary objectives include overall
survival, progression-free survival, and toxicity.
Inclusion Criteria:
- Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or
metastasis Measurable disease (> 1 X 1 cm) by CXR, CT scan or MRI,Age > 18, KPS >
60% , Cre < 1.5mg/dl, AST/ALT < 3.5 X N, Bil < 2.0mg/dl WBC > 4,000/mm3, ANC > 2,000/
mm3, Plt > 100,000/mm3
Exclusion Criteria:
- Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only
(except > 2 months)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Principal Investigator
Ann-Lii Cheng, M.D., Ph.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Oncology, National Taiwan University hospital
Authority:
Taiwan: Department of Health
Study ID:
159I9
NCT ID:
NCT00154700
Start Date:
January 2001
Completion Date:
July 2005
Related Keywords:
- Esophageal Cancer
- Combination,Chemotherapy,Esophageal Cancer
- Esophageal Diseases
- Esophageal Neoplasms
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