search
Back to results

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

Primary Purpose

Neoplasms, Unknown Primary

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Unknown Primary focused on measuring Neoplasms, Unknown Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Integrated Community Oncology Network
  • AP&S Oncology & Hematology Northside
  • Greenview Regional Hospital
  • Consultants in Blood Disorders and Cancer
  • Baton Rouge General Medical Center
  • Oncology Hematology Care
  • Reading Hospital Regional Cancer Center
  • Spartanburg Regional Medical Center
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin/Capecitabine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Full Information

First Posted
September 12, 2005
Last Updated
October 18, 2013
Sponsor
SCRI Development Innovations, LLC
Collaborators
Roche Pharma AG, Sanofi-Synthelabo
search

1. Study Identification

Unique Protocol Identification Number
NCT00193609
Brief Title
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Official Title
A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Roche Pharma AG, Sanofi-Synthelabo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Unknown Primary
Keywords
Neoplasms, Unknown Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin/Capecitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
130 mg/m2 IV day 1 of 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
AP&S Oncology & Hematology Northside
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Greenview Regional Hospital
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42104
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Reading Hospital Regional Cancer Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20209610
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs