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Sponsors and Collaborators: |
University of Wisconsin, Madison Bayer Health Care Pharmaceuticals Sanofi-Aventis |
Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00634751 |
This study involves the use of oxaliplatin, capecitabine, and sorafenib which are all drugs approved by the Food and Drug Administration (FDA) for use in the treatment of different cancers. Their use in this exact combination is considered experimental for the treatment of pancreas and biliary tract; however the combination has been tested in a preliminary trial. We are also testing a survey designed. The purpose of this research study is to investigate the chemotherapy drug sorafenib in combination with oxaliplatin and capecitabine chemotherapies for the treatment of pancreas and biliary tract cancers.to help patients report their side effects from chemotherapy treatments.
Condition | Intervention | Phase |
Pancreatic Neoplasms Bile Duct Neoplasms |
Drug: Oxaliplatin Drug: Capecitabine Drug: Sorafenib |
Phase I Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Capecitabine Sorafenib Sorafenib tosylate Oxaliplatin Dextrose |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma" |
Estimated Enrollment: | 66 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Oxaliplatin + Oral Capecitabine + Sorafenib
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Drug: Oxaliplatin
On days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Following the infusion of oxaliplatin, the infusion line should be flushed with Dextrose 5% in Water.
Drug: Capecitabine
Each course of oral capecitabine administration will commence following administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses as above, commencing with each cycle of therapy. Because capecitabine is provided in fixed dose forms, rounding will be necessary. Rounding will be to the nearest 150 mg on a per dose basis.
Drug: Sorafenib
Cohort 1 will receive 200 mg of sorafenib orally twice daily, cohort 2 will receive 400 mg orally twice daily, both beginning on the first day of the first cycle (see section 9.1). If needed, cohort -1 will be used, at 200 mg of sorafenib once daily. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). Cohort I (Dose escalation phase) Agent Dose Route Day Cycle length Sorafenib 200 mg BID Oral Daily Every 28 days If 1/3 patients develop a DLT, enroll 3 patients at dose level -1 Sorafenib 200 mg po qd. Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length Sorafenib 400 mg BID Oral Daily Every 28 days |
Primary Objectives
Secondary Objectives
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cancer Connect | 800-622-8922 | |
Contact: Kelly Richie | 608-263-7283 | kr2@medicine.wisc.edu |
United States, Wisconsin | |||||
University of Wisconsin | Recruiting | ||||
Madison, Wisconsin, United States, 53792 |
University of Wisconsin, Madison |
Bayer Health Care Pharmaceuticals |
Sanofi-Aventis |
Principal Investigator: | Noelle K LoConte, M.D. | University of Wisconsin, Madison |
Responsible Party: | UW Paul P. Carbone Comprehensive Cancer Center ( Noelle K. LoConte, M.D. ) |
Study ID Numbers: | 2007-0248 |
First Received: | March 5, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00634751 |
Health Authority: | United States: Institutional Review Board |
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