Metastatic Liver CancerPhase 1NCT00604409
Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
A Phase 1 study testing SIRT and capecitabine in people with Metastatic Liver Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Cancer
- What is being tested?
- SIRT and capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate liver function
- Adequate performance status
Who cannot join
- Significant extrahepatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
Read the detailed description
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
- Metastatic Liver Cancer
- Being tested
- SIRT, capecitabine
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRTRadiation
Also called selective internal radiation therapy
Undergo SIRT
capecitabineDrug
Also called CAPE, Ro 09-1978/000, Xeloda
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: SIRT; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.
Measured: ongoing
Secondary outcomes (1)
Efficacy
Measured: response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionJun 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Liver CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sirtex Medical
- Responsible party
- Sponsor
- Investigators
- Steven J. Cohen, M.D., Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604409
- Sponsor's protocol ID
- FCCC04043
- Other IDs
- NCI-2010-01936
- Status last verified
- Sep 2015
- First submitted
- 28 Dec 2007
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00604409
- Acronym / sponsor ID
- FCCC04043
- Conditions
- Metastatic Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Sirtex Medical
- Study start
- Apr 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.
Detailed description
Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SIRT and capecitabine) | Experimental | Radiation: SIRT, Drug: capecitabinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adequate liver function
- Adequate performance status
Key exclusion criteria (1 listed)
- Significant extrahepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRTAlso: selective internal radiation therapyUndergo SIRT | Radiation | Treatment (SIRT and capecitabine) |
| capecitabineAlso: CAPE, Ro 09-1978/000, XelodaGiven PO | Drug | Treatment (SIRT and capecitabine) |
Primary outcome
To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer.
Time frame: ongoing
1 secondary outcome
Efficacy
Time frame: response rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven J. Cohen, M.D. study chair
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIRT and capecitabine in people with Metastatic Liver Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety, toxicity, and recommended phase II dose (RPTD) of capecitabine when administered concurrently with SIR-Spheres in patients with advanced cancer. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.