Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

National Taiwan University

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00154700

159I9

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)