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| Sponsored by: |
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 |
| Genetics Home Reference related topics: | bladder cancer |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Fluorouracil |
| 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| Contact: Hana Chen-Walden, MD | +1.617.559.0033 | hana.chen-walden@euclinreg.com |
| United States, Florida | |||||
| Tampa General Hospital | Recruiting | ||||
| Tampa, Florida, United States, 33601 | |||||
| Contact: Jennifer Cooper, CRA 813-844-4218 jcooper@health.usf.edu | |||||
| Principal Investigator: Alexander Rosemurgy, MD | |||||
| United States, Massachusetts | |||||
| Boston Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02118 | |||||
| Contact: Rebecca Brown, RN 617-414-1828 becky.brown@bmc.org | |||||
| Principal Investigator: Kevan Leighton Hartshorn, MD | |||||
| United States, Michigan | |||||
| University of Michigan, Comprehensive Cancer Center | Recruiting | ||||
| Ann Arbor, Michigan, United States, 48109 | |||||
| Contact: Kate Harper 734-647-9112 kateharper@med.umich.edu | |||||
| Principal Investigator: Mark Zalupski, M.D. | |||||
| United States, Ohio | |||||
| Barrett Cancer Center | Recruiting | ||||
| Cincinnati, Ohio, United States, 45267-0501 | |||||
| Contact: Shante Stephens 513-558-0553 StepheS@ucmail.uc.edu | |||||
| Principal Investigator: Malek Safa, M.D. | |||||
| Pro-Pharmaceuticals |
More Information
| Study ID Numbers: | DAVFU-007 |
| First Received: | October 10, 2006 |
| Last Updated: | December 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00386516 |
| Health Authority: | United States: Food and Drug Administration |
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