Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Neoplasms, Unknown Primary
About this trial
This is an interventional treatment trial for Neoplasms, Unknown Primary focused on measuring Neoplasms, Unknown Primary
Eligibility Criteria
Inclusion Criteria: To be included in this study, you must meet the following criteria: Histologically confirmed carcinoma of unknown primary site Progressive disease after treatment with one previous chemotherapy regimen. Treatment with one previous immunotherapy or biotherapy regimen. No previous treatment with oxaliplatin, capecitabine, or 5-FU. Previous treatment with other platinum agents Patients must have measurable or evaluable disease ECOG Performance Status more than 2 Adequate bone marrow, liver and kidney function Understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of treatment of any invasive malignancy within the last 5 years Coexistent medical illnesses Clinically significant cardiac disease Preexisting peripheral neuropathy > grade 1 Lack of physical integrity of the upper gastrointestinal tract Pre-existing uncontrolled coagulopathy Women who are pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Sites / Locations
- Integrated Community Oncology Network
- AP&S Oncology & Hematology Northside
- Greenview Regional Hospital
- Consultants in Blood Disorders and Cancer
- Baton Rouge General Medical Center
- Oncology Hematology Care
- Reading Hospital Regional Cancer Center
- Spartanburg Regional Medical Center
- Chattanooga Oncology Hematology Associates
- Tennessee Oncology, PLLC
Arms of the Study
Arm 1
Experimental
Oxaliplatin/Capecitabine
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.