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| Sponsor: | Pro-Pharmaceuticals |
|---|---|
| Information provided by: | Pro-Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00386516 |
Purpose
The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule DAVANAT is beneficial in treating advanced gall bladder and bile duct cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of the Bile Duct Gallbladder Cancer |
Drug: DAVANAT in combination with 5-Fluorouracil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2, Multi-Center, Open-Label Trial to Evaluate Efficacy and Safety of DAVANAT in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer |
| Estimated Enrollment: | 42 |
| Study Start Date: | September 2006 |
Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with DAVANAT plus 5-Fluorouracil (DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| University of Michigan, Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Ohio | |
| Barrett Cancer Center | |
| Cincinnati, Ohio, United States, 45267-0501 | |
More Information
| Study ID Numbers: | DAVFU-007 |
| Study First Received: | October 10, 2006 |
| Last Updated: | May 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00386516 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cholangiocarcinoma bile duct biliary intra-hepatic extra-hepatic gall bladder |
cancer carcinoma metastatic metastasis advanced recurrent |
|
Gallbladder Diseases Antimetabolites Biliary Tract Neoplasms Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Therapeutic Uses Biliary Tract Diseases Fluorouracil Gallbladder Neoplasms Bile Duct Neoplasms |