Phase 2
N=33
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Stage II Gallbladder Cancer · Stage IIIA Gallbladder Cancer · Stage IIIB Gallbladder Cancer · Stage IVA Gallbladder Cancer · Stage IVB Gallbladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00075504 ↗Enrolled (actual)
33
Serious AEs
93.9%
Results posted
Sep 2015
Primary outcome: Primary: Response Rate According to RECIST Criteria — 3; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- triapine (Drug); gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate According to RECIST Criteria |
3; 0 | — |
| SECONDARY Progression Free Survival |
3.7; 3.6 | — |
| SECONDARY Overall Survival |
10.3; 3.6 | — |
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, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.
Eligibility Criteria
Inclusion Criteria
- 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 = = 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00075504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.