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Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.

NCT00209690 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-05-26

No results posted yet for this study

Summary

A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Taxotere

X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

5-FU

800 mg/m2, CIV (conti.in the vein) on day 1\~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Briplatin

15 mg/m2, IV (in the vein) on day 1\~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • Hokkaido University Hospital

    collaborator OTHER

  • Hokkaido Gastrointestinal Cancer Study Group

    lead OTHER

Principal Investigators

  • Masahiro Asaka, MD, PhD · Hokkaido Gastrointestinal Cancer Study Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00209690 on ClinicalTrials.gov