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

Phase 2

Completed

• Conditions: Neoplasms, Unknown Primary
• Interventions: Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT00193609
• Lead Sponsor: SCRI Development Innovations, LLC

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 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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-04
• Study Completion: 2009-01
• Results First Submitted: 2013-08-15
• Results First Submitted QC: 2013-08-15
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-18
• Results First Posted: 2013-10-21
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxaliplatin/Capecitabine	Oxaliplatin	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.
Oxaliplatin/Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	18 months	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	18 months	Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Trial Locations

Locations (10)

Chattanooga Oncology Hematology Associates; 🇺🇸 Chattanooga, Tennessee, United States

Greenview Regional Hospital; 🇺🇸 Bowling Green, Kentucky, United States

Baton Rouge General Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Consultants in Blood Disorders and Cancer; 🇺🇸 Louisville, Kentucky, United States

Reading Hospital Regional Cancer Center; 🇺🇸 West Reading, Pennsylvania, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States

Integrated Community Oncology Network; 🇺🇸 Jacksonville, Florida, United States

AP&S Oncology & Hematology Northside; 🇺🇸 Terre Haute, Indiana, United States

Spartanburg Regional Medical Center; 🇺🇸 Spartanburg, South Carolina, United States