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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

September 12, 2005
October 18, 2013
September 2004
April 2008   (final data collection date for primary outcome measure)
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
Overall response rate
Complete list of historical versions of study NCT00193609 on ClinicalTrials.gov Archive Site
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.
  • Progression-free survival
  • Overall survival
Not Provided
Not Provided
 
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms, Unknown Primary
  • 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
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.
Interventions:
  • Drug: Oxaliplatin
  • Drug: Capecitabine
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 Cannon Oncology Research Consortium. Cancer. 2010 May 15;116(10):2448-54. doi: 10.1002/cncr.25029.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2009
April 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00193609
SCRI UNKPRI 14
No
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
  • Roche Pharma AG
  • Sanofi-Synthelabo
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP