Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborators:
Roche Pharma AG
Sanofi-Synthelabo
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193609
First received: September 12, 2005
Last updated: May 3, 2011
Last verified: May 2011
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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: | Allocation: Non-Randomized 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 Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| 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: 1
Oxaliplatin + Capecitabine
|
Drug: Oxaliplatin
Oxaliplatin
Drug: Capecitabine
Capecitabine
|
Detailed Description:
Upon determination of eligibility, patients will be receive:
- Oxaliplatin + Capecitabine
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
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
Sarah Cannon Research Institute
Roche Pharma AG
Sanofi-Synthelabo
Investigators
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | John D. Hainsworth, Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193609 History of Changes |
| Other Study ID Numbers: | SCRI UNKPRI 14, OX-03-123 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sarah Cannon Research Institute:
|
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 Oxaliplatin Capecitabine |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013