Status:
COMPLETED
Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Chang Gung Memorial Hospital
Changhua Christian Hospital
Conditions:
Biliary Tract Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 endpoin...
Detailed Description
5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies. The use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of cancers, including c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00201305
Start Date
July 1 2002
End Date
August 1 2012
Last Update
April 1 2009
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100