NCT00604409

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

8.2 years

First QC Date

December 28, 2007

Last Update Submit

September 3, 2015

Conditions

Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.

    ongoing

Secondary Outcomes (1)

  • Efficacy

    response rate

Study Arms (1)

Treatment (SIRT and capecitabine)

EXPERIMENTAL

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.

Radiation: SIRTDrug: capecitabine

Interventions

SIRTRADIATION

Undergo SIRT

Also known as: selective internal radiation therapy
Treatment (SIRT and capecitabine)
capecitabineDRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda
Treatment (SIRT and capecitabine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adequate liver function
  • Adequate performance status

You may not qualify if:

  • Significant extrahepatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

SirtuinsCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Group III Histone DeacetylasesHistone DeacetylasesAmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesADP Ribose TransferasesPentosyltransferasesGlycosyltransferasesTransferasesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Steven J. Cohen, M.D.

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 30, 2008

Study Start

April 1, 2006

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(1)