Status:
COMPLETED
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Roche Pharma AG
Sanofi-Synthelabo
Conditions:
Neoplasms, Unknown Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcin...
Detailed Description
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00193609
Start Date
September 1 2004
End Date
January 1 2009
Last Update
November 11 2013
Active Locations (10)
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1
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
2
AP&S Oncology & Hematology Northside
Terre Haute, Indiana, United States, 47804
3
Greenview Regional Hospital
Bowling Green, Kentucky, United States, 42104
4
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207