Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT00154700
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-01
• Status Verified: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Last Update Submitted: 2005-12-19
• Last Update Posted: 2005-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival
Progression-free survival
Toxicity

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan