Clinical trial NCT00634751
Conditions: Pancreatic Neoplasms Bile Duct Neoplasms
Keywords: advanced pancreatic and biliary tract carcinomas
Sponsor: University of Wisconsin, Madison
Start date: 2008-02-01; Completion date: 2010-07-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
Primary Objectives

* To assess the overall safety of sorafenib when administered with "the 2DOC regimen" capecitabine and oxaliplatin in patients with advanced or metastatic pancreas or biliary tract cancers.
* To define the dose limiting toxicity and maximally tolerated dose of this combination.
* To assess the clinical response rate (stable, partial and complete responses) of the combination in patients with advanced or metastatic pancreas or biliary tract cancers.

Secondary Objectives

* To define the time to progression and overall survival for patients treated with this regimen.
* To evaluate the congruency of the Adverse Events Self-Report Survey in determining patient reported side effects of treatment

Arms: arm 1: Cohort 1: 200mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib arm 2: Cohort 2: 400mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib arm 3: Oxaliplatin + Oral Capecitabine + Sorafeni arm 4: Oxaliplatin + Oral Capecitabine + Sorafeni
Interventions: intervention 1: Oxaliplatin intervention 2: Capecitabine intervention 3: Sorafenib
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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

Protocol documents: