Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer - Full Text View

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00154700

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: Paclitaxel,Cisplatin,5-Fu,Folic Acid	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Fluorouracil Folic acid Cisplatin Paclitaxel

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Response rate

Secondary Outcome Measures:

Overall survival
Progression-free survival
Toxicity

Estimated Enrollment:	40
Study Start Date:	January 2001
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154700

Locations

Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00154700 History of Changes
Other Study ID Numbers:	159I9
Study First Received:	September 8, 2005
Last Updated:	December 19, 2005
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Combination,Chemotherapy,Esophageal Cancer

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Cisplatin
Paclitaxel
Folic Acid
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012