Clinical trialPhase 1 / Phase 2Completed
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"
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- February 2008
- Expected end
- July 2010
- Enrollment
- 48 participants
- Sites
- 1
- Primary outcomes
- Overall Response Rate
- Sponsor
- Other
- Results posted
- 2017-08-08
- Last update
- 26 November 2019
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Response Rate [Up to 18 months]. Number, participants. Partial Response: Phase I: 200mg Sorafenib+2DOC (n=7): 1; Phase I: 400mg Sorafenib BID+2DOC (n=3): 1; Phase II: Pancreatic Cancer (n=20): 3; Phase II: Biliary Tract Cancer (n=7): 1. Stable Disease: Phase I: 200mg Sorafenib+2DOC (n=7): 5; Phase I: 400mg Sorafenib BID+2DOC (n=3): 2; Phase II: Pancreatic Cancer (n=20): 11; Phase II: Biliary Tract Cancer (n=7): 5. Progressive Disease: Phase I: 200mg Sorafenib+2DOC (n=7): 1; Phase I: 400mg Sorafenib BID+2DOC (n=3): 0; Phase II: Pancreatic Cancer (n=20): 6; Phase II: Biliary Tract Cancer (n=7): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [Up to 18 months]. Median, Months (95% Confidence Interval). Phase II: Pancreatic Cancer (n=19): 6.0 (2.5 to 9.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 18 months]. Median, Months (95% Confidence Interval). Phase II: Pancreatic Cancer (n=19): 8.1 (3.5 to 10.9).