Status:
COMPLETED
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage II Gallbladder Cancer
Stage IIIA Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, s...
Detailed Description
OBJECTIVES: I. To determine the objective response rates for the combination of triapine and gemcitabine in patients with primary tumors of the biliary ducts and gall bladder. II. To assess the toxi...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the biliary ducts that is unresectable and/or metastatic; this can include unresectable or metastatic carcinomas of the Ampulla of Vater. In addition, unresectable or metastatic gall bladder carcinoma will be allowed
- Measurable disease
- No prior chemotherapy
- Life expectancy of greater than 3 months
- ECOG performance status =\< 2 (Karnofsky \>= 60%)
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Creatinine within normal institutional limits
- Patients may have mildly abnormal liver function defined as a total bilirubin \> ULN and =\< 3x the institutional upper limits of normal (includes CTCAE v.3 grades 1-2 hyperbilirubinemia)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine or gemcitabine
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Uncontrolled pulmonary disease including asthma, chronic bronchitis and COPD or with requirements for chronic oxygen use
- Pregnant or lactating women
- HIV infection
- Patients with G6PD deficiency will be excluded in view of the potential for methemoglobinemia
- Psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00075504
Start Date
November 1 2003
End Date
January 1 2009
Last Update
September 28 2015
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467-2490