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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Unknown Primary

Treatments: Drug: Capecitabine; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193609

SCRI UNKPRI 14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Oxaliplatin/Capecitabine

Experimental group

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.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine