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

NCT ID: NCT00193609

Last Updated: 2013-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neoplasms, Unknown Primary

Keywords

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Neoplasms, Unknown Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxaliplatin/Capecitabine

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.

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

130 mg/m2 IV day 1 of 21 day cycle

Capecitabine

Intervention Type DRUG

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

Interventions

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Oxaliplatin

130 mg/m2 IV day 1 of 21 day cycle

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Other Intervention Names

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Eloxatin Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Integrated Community Oncology Network

Jacksonville, Florida, United States

Site Status

AP&S Oncology & Hematology Northside

Terre Haute, Indiana, United States

Site Status

Greenview Regional Hospital

Bowling Green, Kentucky, United States

Site Status

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Site Status

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Reading Hospital Regional Cancer Center

West Reading, Pennsylvania, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Hainsworth JD, Spigel DR, Burris HA 3rd, Shipley D, Farley C, Macias-Perez IM, Barton J, Greco FA. Oxaliplatin and capecitabine in the treatment of patients with recurrent or refractory carcinoma of unknown primary site: a phase 2 trial of the Sarah Cannon Oncology Research Consortium. Cancer. 2010 May 15;116(10):2448-54. doi: 10.1002/cncr.25029.

Reference Type RESULT
PMID: 20209610 (View on PubMed)

Other Identifiers

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SCRI UNKPRI 14

Identifier Type: -

Identifier Source: org_study_id