Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154700
First received: September 8, 2005
Last updated: December 19, 2005
Last verified: July 2005

September 8, 2005
December 19, 2005
January 2001
Not Provided
Response rate
Same as current
Complete list of historical versions of study NCT00154700 on ClinicalTrials.gov Archive Site
  • Overall survival
  • Progression-free survival
  • Toxicity
Same as current
Not Provided
Not Provided
 
Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
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 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
Drug: Paclitaxel,Cisplatin,5-Fu,Folic Acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2005
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00154700
159I9
Not Provided
Not Provided
National Taiwan University Hospital
Not Provided
Study Chair: Ann-Lii Cheng, M.D., Ph.D. Department of Oncology, National Taiwan University hospital
Study Chair: Ann-Lii Cheng, M.D.,Ph.D Department of Oncology, National Taiwan University Hospital
National Taiwan University Hospital
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP