Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Bile Duct Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Sorafenib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Cohort 1: 200mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib

Cohort 2: 400mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib

Oxaliplatin + Oral Capecitabine + Sorafeni

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.

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.

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

Noelle K LoConte, M.D.

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.

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

CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma

A Phase I/II STudy of Oxaliplatin, Oral Capecitabine and Sorafenib in Patients With Advanced Pancreatic and Biliary Carcinoma"

Response rate of participant to treatment

Time to progression, defined as number of days from day of first study drug administration to the day the patient experiences an event of disease progression or death; summarized using point estimates of the median time to progression and associated 95% confidence intervals for each stratum separately.

Overall survival, defined as number of days from the day of first study drug administration to the day the patient dies, summarized using point estimates of the median time to progression, and associated 95% confidence intervals

Bayer

Sanofi

University of Wisconsin, Madison

Cohort 1: 200mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib

Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.

Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.

Sorafenib: 200 mg of sorafenib orally twice daily, beginning on the first day of the first cycle. If needed, cohort -1 will be used, at 200 mg of sorafenib once daily.

Cohort I

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.

Phase I: 200mg Sorafenib+2DOC

Cohort 2: 400mg Sorafenib+2DOC

Oxaliplatin + Oral Capecitabine + Sorafenib

Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.

Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.

Sorafenib: 400 mg of sorafenib 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.

Cohort II (Phase II studies at MTD) Agent Dose Route Day Cycle length

Sorafenib 400 mg BID Oral Daily Every 28 days

Phase I: 400mg Sorafenib BID+2DOC

Oxaliplatin + Oral Capecitabine + Sorafeni

Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.

Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.

Sorafenib: 200mg of sorafenib orally twice daily, both beginning on the first day of the first cycle.

Phase II: Pancreatic Cancer

Phase II: Biliary Tract Cancer

Oxaliplatin + Oral Capecitabine + Sorafeni

Oxaliplatin: Days 1 and 15 of each 28 day treatment cycle, patients receive oxaliplatin 85 mg/m2 as a 2-hour IV infusion. Next, the infusion line should be flushed with Dextrose 5% in Water.

Capecitabine: Oral capecitabine administration will start after administration of oxaliplatin. Capecitabine 2250 mg/m2 will be given every 8 hours for a total of 6 doses, commencing with each cycle of therapy. Capecitabine is provided in fixed dose forms, and rounding will be to the nearest 150 mg on a per dose basis.

Sorafenib: 400 mg of sorafenib 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.

Total

=< 50 years of age

50-59 years of age

60-69 years of age

70-79 years of age

>= 80 years of age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants with histologically or cytologically confirmed adenocarcinoma of the pancreas or biliary tract were enrolled.

Dr. Noelle LoConte

Partial Response

Stable Disease

Progressive Disease

Overall Response Rate

PFS was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.

Progression-free Survival (PFS)

Overall survival was not a pre-specified Phase I outcome, and no data was collected or analyzed. No data was collected for Phase II biliary tract participants.

Spots Global Cancer Trial Database for CO07204-Phase I/II of Oxaliplatin, Capecitabine & Sorafenib for Advanced Pancreatic & Biliary Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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