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Tracking Information | |||||
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First Received Date † | January 9, 2004 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | January 2004 | ||||
Current Primary Outcome Measures † |
Objective response [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00075504 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer | ||||
Official Title † | A Phase II Study Of Triapine In Combination With Gemcitabine In Adenocarcinoma Of The Billiary Ducts And Gall Bladder | ||||
Brief Summary | RATIONALE: 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. PURPOSE: 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. |
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Detailed Description | OBJECTIVES:
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. PROJECTED ACCRUAL: A total of 31-78 patients (10-29 with liver dysfunction and 21-49 without liver dysfunction) will be accrued for this study within 10-24.5 months. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 78 | ||||
Completion Date | |||||
Estimated Primary Completion Date | August 2005 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00075504 | ||||
Responsible Party | |||||
Secondary IDs †† | AECM-0803945, NCI-6254 | ||||
Study Sponsor † | Albert Einstein College of Medicine of Yeshiva University | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | February 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |