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

NCT00193609 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-11-11

Study results available
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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.

Conditions

  • Neoplasms, Unknown Primary

Interventions

DRUG

Oxaliplatin

130 mg/m2 IV day 1 of 21 day cycle

DRUG

Capecitabine

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • John D. Hainsworth, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-04-30
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193609 on ClinicalTrials.gov