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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 22, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute SCRI Oncology Research Consortium Hoffmann-La Roche Sanofi-Synthelabo
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193609

Purpose

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.

Condition	Intervention	Phase
Neoplasms, Unknown Primary	Drug: Oxaliplatin Drug: Capecitabine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2004
Study Completion Date:	January 2009
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oxaliplatin + Capecitabine	Drug: Oxaliplatin Oxaliplatin Drug: Capecitabine Capecitabine

Detailed Description:

Upon determination of eligibility, patients will be receive:

Oxaliplatin + Capecitabine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193609

Locations

United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Indiana
AP&S Oncology & Hematology Northside
Terre Haute, Indiana, United States, 47804
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
Greenview Regional Hospital
Bowling Green, Kentucky, United States, 42104
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Reading Hospital Regional Cancer Center
West Reading, Pennsylvania, United States, 19612
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404

Sponsors and Collaborators

Sarah Cannon Research Institute

SCRI Oncology Research Consortium

Hoffmann-La Roche

Sanofi-Synthelabo

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	Sarah Cannon Research Institute ( John D. Hainsworth )
Study ID Numbers:	SCRI UNKPRI 14, OX-03-123
Study First Received:	September 12, 2005
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00193609 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:

Neoplasms, Unknown Primary

Study placed in the following topic categories:

Antimetabolites
Oxaliplatin
Capecitabine
Neoplasms, Unknown Primary

Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms, Unknown Primary
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplastic Processes
Oxaliplatin
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009