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
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014