Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

NCT ID: NCT00604409

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2015-01-31

Brief Summary

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This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Detailed Description

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Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Conditions

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Metastatic Liver Cancer

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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Treatment (SIRT and capecitabine)

Patients receive capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo SIRT on day 2 and may undergo a second course of SIRT on day 58.

Group Type EXPERIMENTAL

SIRT

Intervention Type RADIATION

Undergo SIRT

capecitabine

Intervention Type DRUG

Given PO

Interventions

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SIRT

Undergo SIRT

Intervention Type RADIATION

capecitabine

Given PO

Intervention Type DRUG

Other Intervention Names

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selective internal radiation therapy CAPE, Ro 09-1978/000, Xeloda

Eligibility Criteria

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Inclusion Criteria

* Adequate liver function
* Adequate performance status

Exclusion Criteria

* Significant extrahepatic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirtex Medical

INDUSTRY

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven J. Cohen, M.D.

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-01936

Identifier Type: REGISTRY

Identifier Source: secondary_id

FCCC04043

Identifier Type: -

Identifier Source: org_study_id

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