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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site

Conditions
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Neoplasms, Unknown Primary

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin/Capecitabine<br>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. | Drug: Oxaliplatin<br>* 130 mg/m2 IV day 1 of 21 day cycle<br>* Other names: Eloxatin;Drug: Capecitabine<br>* 1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Length of time, in months, that patients were alive from their first date of protocol treatment until death. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Unknown Primary