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NCT Number: NCT00193609

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

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.

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Key information

Conditions

Neoplasms, Unknown Primary Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Integrated Community Oncology Network, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

130 mg/m2 IV day 1 of 21 day cycle

Other names: Eloxatin

Capecitabine

Drug

1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle

Other names: Xeloda

Primary outcomes

  1. Progression Free Survival

    Time frame: 18 months

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary outcomes

  1. Overall Survival

    Time frame: 18 months

    Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Roche Pharma AG
  • Sanofi-Synthelabo

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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