Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154700
• Other study ID #: 159I9
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: December 19, 2005
• Start date: January 2001
• Est. completion date: July 2005

Study information

• Verified date: July 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Paclitaxel,Cisplatin,5-Fu,Folic Acid

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate
Secondary	Overall survival
Secondary	Progression-free survival
Secondary	Toxicity