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Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer

NCT01234051 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-12-12

No results posted yet for this study

Summary

1. Goals

* The primary goal of this phase II trial is to:

evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy

Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
2. Design

The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Docetaxel, Oxaliplatin

1\. Treatment Schedule 1.1. Docetaxel schedule Docetaxel 35 mg/m2 is administered on day 1 and day 8 by intravenously in 100 mL of 5% dextrose solution over 30 minutes. Dexamethasone 8mg is intravenously administered before 30 minutes, and then orally 4mg every 12 hours over 48 hours. In the event of a hypersensitivity reaction, dimethidine maleate, epinephrine, and intravenous fluids will be required. 1.2. Oxaliplatin schedule Oxaliplatin 100 mg/m2 is given on day 1 by intravenous infusion in 500 mL of 5% dextrose solution over 120 minutes. Therapy will be repeated every 21 days.

Sponsors & Collaborators

  • Korean South West Oncology Group

    lead NETWORK

Principal Investigators

  • Eun Ki Song · Chonbuk National Universitiy Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • South Korea

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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 NCT01234051 on ClinicalTrials.gov