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A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Unknown Primary

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Trial Information

A Phase II Trial of Oxaliplatin and Capecitabine in the Treatment of Patients With Relapsed/Refractory Carcinoma of Unknown Primary Site


Upon determination of eligibility, patients will be receive:

- Oxaliplatin + Capecitabine


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI UNKPRI 14

NCT ID:

NCT00193609

Start Date:

September 2004

Completion Date:

January 2009

Related Keywords:

  • Neoplasms, Unknown Primary
  • Neoplasms, Unknown Primary
  • Neoplasms
  • Carcinoma
  • Neoplasms, Unknown Primary

Name

Location

Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Consultants in Blood Disorders and Cancer Louisville, Kentucky  40207
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Reading Hospital Regional Cancer Center West Reading, Pennsylvania  19612
AP&S Oncology & Hematology Northside Terre Haute, Indiana  47804
Greenview Regional Hospital Bowling Green, Kentucky  42104