NCT00201305

Brief Summary

This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

April 1, 2009

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

March 30, 2009

Conditions

Biliary Tract Disease

Outcome Measures

Primary Outcomes (1)

  • To determine the response rate of weekly gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for patients with advanced or metastatic biliary tract cancer.

Secondary Outcomes (5)

  • To determine:

  • 1.Toxicity profile of gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for advanced or metastatic biliary tract cancer.

  • 2.Time to disease progression

  • 3.Overall survival

  • 4.Quality of life

Interventions

Gemcitabine+5FU+LeucovorinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven carcinoma of the biliary tract, including gallbladder carcinoma and cholangiocarcinoma. The disease should be either locally advanced to the extent that curative surgery is impossible or with documented distant metastasis.
  • Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography (CT) scan).
  • Age \> 18 years. For patients older than 70 years of age, detailed evaluation of the organ function reserves must be done before enrollment unto protocol treatment.
  • Karnofsky performance status\> 60%
  • Adequate bone marrow reserves, defined as white blood cell (WBC)\>4,000/ml, absolute neutrophil count (ANC)\> 1,500/ml, platelet\> 150,000/ml.
  • Liver transaminases \<5 times upper normal limits; total bilirubin \<3 mg/dl; serum creatinine \< 1.5 mg/dl
  • Serum triglyceride level \>70 mg/dl
  • No prior cytotoxic chemotherapy. Previous radiotherapy is allowed if the treatment was completed at least 6 weeks before the enrollment onto this study.
  • Patients of childbearing age should have effective contraception during the study period.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.

You may not qualify if:

  • Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
  • Patients who refuse port-A catheter implantation
  • Patients with brain or leptomeningeal metastases.
  • Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
  • Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
  • Life expectancy less than 2 months.
  • Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Patients who have previous malignancy except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Links

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Ann-Li Cheng, PHD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2002

Study Completion

August 1, 2012

Last Updated

April 1, 2009

Record last verified: 2005-09

Locations

TW(1)