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

Neoplasms, Unknown Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193609
• Other study ID #: SCRI UNKPRI 14
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: October 18, 2013
• Start date: September 2004
• Est. completion date: January 2009

Study information

• Verified date: October 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Unknown Primary

Intervention

Drug:
• Oxaliplatin
130 mg/m2 IV day 1 of 21 day cycle
• Capecitabine
1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Roche Pharma AG, Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hainsworth JD, Spigel DR, Burris HA 3rd, Shipley D, Farley C, Macias-Perez IM, Barton J, Greco FA. Oxaliplatin and capecitabine in the treatment of patients with recurrent or refractory carcinoma of unknown primary site: a phase 2 trial of the Sarah Canno — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival	Length of time, in months, that patients were alive from their first date of protocol treatment until death.	18 months	No

External Links

•   Published article in Cancer