- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00075504
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder
Study Overview
Status
Conditions
Intervention / Treatment
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 toxicities and recovery from toxicities for patients with biliary duct and gall bladder tumors treated with the combination of triapine and gemcitabine.
III. To determine the survival and progression free survival of patients with biliary and gall bladder tumors treated with the combination of triapine and gemcitabine.
OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal).
Patients receive 3-AP (Triapine) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR.
Patients are followed every 3 months for up to 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10467-2490
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 =< 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: triapine, gemcitabine
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
|
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate According to RECIST Criteria
Time Frame: Up to 2 years
|
Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.
|
Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Progression Free Survival
Time Frame: Up to 2 years
|
PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allyson Ocean, Montefiore Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Gallbladder Diseases
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Gallbladder Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- NCI-2012-03030
- N01CM62204 (U.S. NIH Grant/Contract)
- U01CA062505 (U.S. NIH Grant/Contract)
- 6254 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage II Gallbladder Cancer
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingStage II Gallbladder Cancer AJCC v8 | Stage IIA Gallbladder Cancer AJCC v8 | Stage IIB Gallbladder Cancer AJCC v8 | Stage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8United States
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Emory UniversityWithdrawnStage II Gallbladder Cancer AJCC v8 | Stage IIA Gallbladder Cancer AJCC v8 | Stage IIB Gallbladder Cancer AJCC v8 | Stage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Stage I Gallbladder Cancer AJCC v8United States
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Mayo ClinicNational Cancer Institute (NCI)CompletedCholangiocarcinoma | Stage III Gallbladder Cancer AJCC v7 | Stage IIIA Gallbladder Cancer AJCC v7 | Stage IIIB Gallbladder Cancer AJCC v7 | Stage IV Gallbladder Cancer AJCC v7 | Stage IVA Gallbladder Cancer AJCC v7 | Stage IVB Gallbladder Cancer AJCC v7United States
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National Cancer Institute (NCI)WithdrawnAdvanced Adult Primary Liver Cancer | Localized Unresectable Adult Primary Liver Cancer | Recurrent Adult Primary Liver Cancer | Recurrent Extrahepatic Bile Duct Cancer | Unresectable Extrahepatic Bile Duct Cancer | Stage II Gallbladder Cancer | Stage IIIA Gallbladder Cancer | Stage IIIB Gallbladder... and other conditions
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National Cancer Institute (NCI)CompletedHilar Cholangiocarcinoma | Advanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Liver Carcinoma | Recurrent Adult Liver Carcinoma | Recurrent Gallbladder Carcinoma | Stage IV Distal Bile Duct Cancer | Unresectable Extrahepatic Bile Duct Carcinoma | Stage II Gallbladder Cancer | Stage... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCholangiocarcinoma | Liver and Intrahepatic Bile Duct Carcinoma | Unresectable Gallbladder Carcinoma | Stage III Gallbladder Cancer AJCC v7 | Stage IIIA Gallbladder Cancer AJCC v7 | Stage IIIB Gallbladder Cancer AJCC v7 | Stage IV Gallbladder Cancer AJCC v7 | Stage IVA Gallbladder Cancer AJCC v7 | Stage... and other conditionsUnited States
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University of NebraskaNational Cancer Institute (NCI); Adherex Technologies, Inc.CompletedPancreatic Adenocarcinoma | Metastatic Pancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IVA Pancreatic Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gallbladder Cancer | Stage IIIB Gallbladder Cancer | Stage IVA Gallbladder Cancer | Stage IVB Gallbladder Cancer | Gallbladder Adenocarcinoma and other conditionsUnited States
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SWOG Cancer Research NetworkNational Cancer Institute (NCI)Active, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Unresectable Extrahepatic... and other conditionsUnited States
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Mayo ClinicNational Comprehensive Cancer NetworkCompletedStage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Refractory Gallbladder Carcinoma | Stage IV Gallbladder Cancer AJCC v8 | Stage IV Distal Bile Duct Cancer AJCC v8 | Stage IV Intrahepatic Bile Duct Cancer AJCC v8 | Stage IVB Gallbladder... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Extrahepatic Bile Duct Carcinoma | Unresectable Gallbladder Carcinoma | Stage IIIA Gallbladder Cancer AJCC v7 | Stage IIIB Gallbladder Cancer AJCC v7 | Stage IVA Gallbladder Cancer AJCC v7 | Stage IVB Gallbladder Cancer AJCC v7 | Stage III Intrahepatic Cholangiocarcinoma AJCC v7 | Stage... and other conditionsUnited States
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Vion PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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Vion PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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Vion PharmaceuticalsCompleted
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National Cancer Institute (NCI)CompletedAcinar Cell Adenocarcinoma of the Pancreas | Duct Cell Adenocarcinoma of the Pancreas | Recurrent Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic CancerUnited States
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Vion PharmaceuticalsCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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National Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer AJCC v6 and v7United States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Primary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial CancerUnited States