Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
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|ClinicalTrials.gov Identifier: NCT00075504|
Recruitment Status : Completed
First Posted : January 12, 2004
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stage II Gallbladder Cancer Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer||Drug: triapine Drug: gemcitabine||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
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
- 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.
- 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.
- Overall Survival [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075504
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Allyson Ocean||Montefiore Medical Center|