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
1 other identifier
interventional
48
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2004
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
October 21, 2013
CompletedNovember 11, 2013
October 1, 2013
3.6 years
September 12, 2005
August 15, 2013
October 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Overall Survival
18 months
Study Arms (1)
Oxaliplatin/Capecitabine
EXPERIMENTALAll 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
1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Roche Pharma AGcollaborator
- Sanofi-Synthelabocollaborator
Study Sites (10)
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
AP&S Oncology & Hematology Northside
Terre Haute, Indiana, 47804, United States
Greenview Regional Hospital
Bowling Green, Kentucky, 42104, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Reading Hospital Regional Cancer Center
West Reading, Pennsylvania, 19612, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related 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 Cannon Oncology Research Consortium. Cancer. 2010 May 15;116(10):2448-54. doi: 10.1002/cncr.25029.
PMID: 20209610RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
September 1, 2004
Primary Completion
April 1, 2008
Study Completion
January 1, 2009
Last Updated
November 11, 2013
Results First Posted
October 21, 2013
Record last verified: 2013-10