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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
Not Enrolling
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:


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:


Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

January 2009

Related Keywords:

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



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