Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site

Completed · Phase 2

Conditions studied: Neoplasms, Unknown Primary

In brief

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 carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.

Key facts

Study ID

NCT00193609

Run by

SCRI Development Innovations, LLC

People needed

48

Starts

2004-09-01

Expected to finish

2009-01-01

Last updated by the study team

2013-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Integrated Community Oncology Network — Jacksonville, Florida, United States
• AP&S Oncology & Hematology Northside — Terre Haute, Indiana, United States
• Greenview Regional Hospital — Bowling Green, Kentucky, United States
• Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
• Baton Rouge General Medical Center — Baton Rouge, Louisiana, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Reading Hospital Regional Cancer Center — West Reading, Pennsylvania, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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