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

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
Sanofi-Synthelabo
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193609
First received: September 12, 2005
Last updated: October 18, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until death.


Enrollment: 48
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
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

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

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
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, see Learn About Clinical Studies.

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
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
Sanofi-Synthelabo
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193609     History of Changes
Other Study ID Numbers: SCRI UNKPRI 14
Study First Received: September 12, 2005
Results First Received: August 15, 2013
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014