Clinical trial NCT00193609: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Unknown Primary
Keywords: Neoplasms, Unknown Primary
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Sanofi-Synthelabo
First posted: 2005-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 18 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Terre Haute
country: United States
facility: AP&S Oncology & Hematology Northside
state: Indiana
city: Bowling Green
country: United States
facility: Greenview Regional Hospital
state: Kentucky
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: West Reading
country: United States
facility: Reading Hospital Regional Cancer Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.