We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00193609
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : October 21, 2013
Last Update Posted : November 11, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Neoplasms, Unknown Primary Drug: Oxaliplatin Drug: Capecitabine Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site
Study Start Date : September 2004
Primary Completion Date : April 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Oxaliplatin/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.
Drug: Oxaliplatin
130 mg/m2 IV day 1 of 21 day cycle
Other Name: Eloxatin
Drug: Capecitabine
1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
Other Name: Xeloda

Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: 18 months ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193609

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
Greenview Regional Hospital
Bowling Green, Kentucky, United States, 42104
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
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
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Roche Pharma AG
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
More Information

Additional Information:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193609     History of Changes
Other Study ID Numbers: SCRI UNKPRI 14
First Posted: September 19, 2005    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: November 11, 2013
Last Verified: October 2013

Keywords provided by SCRI Development Innovations, LLC:
Neoplasms, Unknown Primary

Additional relevant MeSH terms:
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents