XL119 Versus 5-Fluorouracil (5-FU) plus
Leucovorin (LV) in Subjects with Advanced Biliary
Tumors
This study is currently recruiting patients.
Sponsored by: |
Exelixis |
Information provided by: |
Exelixis |
Purpose
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and
leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
Condition
|
Treatment or Intervention |
Phase |
Biliary Tract Cancer
|
Drug: XL119 Drug: 5-Fluorouracil and Leucovorin
|
Phase III
|
MedlinePlus related topics: Bile Duct Diseases; Cancer; Cancer Alternative Therapy; Digestive Diseases; Gallbladder Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase 3 Multicenter, Single-Blind, Randomized
Study of XL119 Versus 5-Fluorouracil (5-FU) plus
Leucovorin (LV) in Subjects with Advanced Biliary
Tumors Not Amenable to Conventional Surgery
Further Study Details:
Expected Total Enrollment:
600
Primary Objective
- To compare survival duration for XL119 and 5-FU/LV treated subjects
Secondary Objectives
- To determine time to progressive disease for XL119 and 5-FU/LV treated subjects
- To evaluate clinical benefit for XL119 and 5-FU/LV treated subjects
- To assess the safety profile of XL119
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
Inclusion Criteria:
- Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma)
that is not amenable to conventional surgical approach
- 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
- Willing and able to sign informed consent
- Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception
with spermicide)
- Women of child-bearing age must have a negative pregnancy test
Laboratory criteria (within 72 hours of first XL119 treatment)
- white blood cell count (WBC) >3000/ µL
- absolute neutrophil count ≥1500/µL
- hemoglobin≥9.5 g/dL
- platelet count ≥100,000/µL
- lymphocyte count <20,000/µL
- normal blood urea nitrogen (BUN)
- serum creatinine within 2.5 times the upper limit of normal
- alanine transaminase (ALT) within 2.5 times the upper limit of normal
- aspartate transaminase (AST) within 2.5 times the upper limit of normal
- bilirubin <3 mg/dL
Exclusion Criteria:
- Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
- Unstable angina, or class III or IV New York Heart Association heart disease
- Central nervous system metastases
- Uncontrolled diabetes mellitus
- Uncontrolled seizure disorder
- Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
- Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during
study participation or 28 days prior to study participation
- Pregnant or breast-feeding
- A known history of human immunodeficiency virus (HIV) infection
Location
and Contact
Information
Michigan Oncology Care Center PLLC, St. Joseph,
Michigan,
49085,
United States; Recruiting
Eric P Lester, M.D., Principal Investigator
New York Queens Hospital Center, Jamaica,
New York,
11432,
United States; Recruiting
Mary M Kemeny, M.D., Principal Investigator
Ohio Gabrail Cancer Center, Canton,
Ohio,
44718,
United States; Recruiting
Nashat Y Gabrail, M.D., Principal Investigator
South Carolina Charleston Hematology Oncology, PA, Charleston,
South Carolina,
29403,
United States; Recruiting
George F. Geils, M.D., Principal Investigator
Study chairs or principal investigators
Harold Keer, M.D., Ph.D., Study Director, Exelixis, Inc.
More Information
Study ID Numbers:
XL119-001
Record last reviewed:
August 2004
Record first received:
August 19, 2004
ClinicalTrials.gov Identifier:
NCT00090025Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10