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3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
This study is currently recruiting patients.
Sponsored by: | Cornell University Medical College |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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: Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have unresectable or metastatic bile duct or gallbladder cancer.
Condition | Treatment or Intervention | Phase |
---|---|---|
unresectable extrahepatic bile duct cancer recurrent gallbladder cancer unresectable gallbladder cancer recurrent extrahepatic bile duct cancer adenocarcinoma of the extrahepatic bile duct |
Drug: 3-AP Drug: gemcitabine Procedure: chemosensitization/potentiation Procedure: chemotherapy |
Phase II |
MedlinePlus related topics: Bile Duct Diseases; Cancer; Cancer Alternative Therapy; Digestive Diseases; Gallbladder Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine in Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer
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 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 10-25 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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