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Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00193609•SCRI Development Innovations, LLC

View on ClinicalTrials.gov

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 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

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (10)

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

Key Dates

Start Date

September 1, 2004

Primary Completion Date

April 1, 2008

Completion Date

January 1, 2009

Last Updated

November 11, 2013

Enrollment

ACTUAL participants

Conditions

Neoplasms, Unknown Primary

Interventions

Oxaliplatin

DRUG

Capecitabine

DRUG