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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Triapine in Combination With Gemcitabine in Adenocarcinoma of the Biliary Ducts and Gall Bladder|
- Response Rate According to RECIST Criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
Other Names:Drug: gemcitabine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075504
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Allyson Ocean||Montefiore Medical Center|