Liver CancerPhase 1NCT00858429
Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
A Phase 1 study testing capecitabine and yttrium Y 90 glass microspheres in people with Liver Cancer and Metastatic Cancer, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Liver Cancer, Metastatic Cancer
- What is being tested?
- capecitabine and yttrium Y 90 glass microspheres
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 8 Jul 2014
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Intrahepatic cholangiocarcinoma
- Metastatic cancer confined to the liver
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- Must have tumor volume ≤ 50% of total liver volume based on visual estimation
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 75,000/mm^3
- Serum creatinine ≤ 2.0 mg/dL
- Serum bilirubin ≤ 1.5 times upper limit of normal
- Albumin ≥ 2.0 g/dL
- No baseline symptoms or laboratory values > grade 2 in severity by NCI CTCAE v 3.0 criteria
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No malabsorption syndrome
- No severe liver dysfunction or pulmonary insufficiency
- No complete occlusion of the main portal vein
- No contraindication to iodine-based contrast agents
- No contraindication to hepatic artery catheterization (e.g., vascular abnormalities or bleeding diathesis)
- No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the liver
- No more than 2 prior therapies for metastatic disease to the liver
- No prior intervention to or compromise of the Ampulla of Vater
- At least 4 weeks since prior and no concurrent sorivudine or brivudine
- No concurrent cimetidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Capecitabine may also make tumor cells more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass microspheres when given together with capecitabine in treating patients with liver cholangiocarcinoma or liver metastases.
Read the detailed description
OBJECTIVES:
- Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in combination with capecitabine in patients with intrahepatic cholangiocarcinoma or liver metastases.
- Characterize the toxicity of this regimen in these patients.
- Determine the time to tumor progression in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also receive yttrium Y 90 glass microspheres by intra-arterial hepatic infusion on days 1-7 of course 2.
After completion of study therapy, patients are followed every 3 months for 2 years.
- Conditions
- Liver Cancer, Metastatic Cancer
- Being tested
- capecitabine, yttrium Y 90 glass microspheres
- Keywords
- advanced adult primary liver cancer, liver metastases, adult primary cholangiocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called C14H15FN3O7, prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)
1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3.
yttrium Y 90 glass microspheresRadiation
The amount of radioactivity required to deliver the desired dose to the liver is calculated using a formula. The dose depends on the cohort upon which the patient is enrolled. Y90 is administered during Cycle #2 on days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (capecitabine, Y90) | Experimental | 2,000mg/m2 capecitabine +110 Y90 Receives: Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres |
| Cohort 2 (capecitabine , Y90) | Experimental | 2,000mg/m2 capecitabine + 130 Y90 Receives: Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres |
| Cohort 3 (capecitabine, Y90) | Experimental | 2,000mg/m2 Capecitabine + 150 Y90 Receives: Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres |
| Cohort 4 (capecitabine, Y90) | Experimental | 2,000 mg/m2 capecitabine = 170 Y90 Receives: Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose of yttrium Y 90
Measured: During treatment and any time up to 6 weeks post-treatment
Toxicity profile of yttrium Y 90
Toxicity will be defined as number of adverse events related to treatment experienced during treatment
Measured: During treatment and up to 30 days post-treatment
Time to tumor progression
Measured: At time of disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study start1 Apr 2009
- Primary completion19 Mar 2014
- Study completion8 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Mulcahy, Northwestern University
- Investigators
- Mary Mulcahy, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858429
- Sponsor's protocol ID
- NU 08I5
- Other IDs
- NU-08I5, STU00007062, NCI-2009-01122
- Status last verified
- Jan 2018
- First submitted
- 6 Mar 2009
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
- ClinicalTrials.gov ID
- NCT00858429
- Acronym / sponsor ID
- NU 08I5
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- advanced adult primary liver cancer, liver metastases, adult primary cholangiocellular carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 19 Mar 2014 (actual)
- Study completion
- 8 Jul 2014 (actual)
- First posted
- 9 Mar 2009 (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.
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Capecitabine may also make tumor cells more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass microspheres when given together with capecitabine in treating patients with liver cholangiocarcinoma or liver metastases.
Detailed description
OBJECTIVES:
- Establish the maximally tolerated dose of yttrium Y 90 glass microspheres in combination with capecitabine in patients with intrahepatic cholangiocarcinoma or liver metastases.
- Characterize the toxicity of this regimen in these patients.
- Determine the time to tumor progression in these patients.
OUTLINE: This is a dose escalation study of yttrium Y 90.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also receive yttrium Y 90 glass microspheres by intra-arterial hepatic infusion on days 1-7 of course 2.
After completion of study therapy, patients are followed every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (capecitabine, Y90) | Experimental | Drug: capecitabine, Radiation: yttrium Y 90 glass microspheres2,000mg/m2 capecitabine +110 Y90 |
| Cohort 2 (capecitabine , Y90) | Experimental | Drug: capecitabine, Radiation: yttrium Y 90 glass microspheres2,000mg/m2 capecitabine + 130 Y90 |
| Cohort 3 (capecitabine, Y90) | Experimental | Drug: capecitabine, Radiation: yttrium Y 90 glass microspheres2,000mg/m2 Capecitabine + 150 Y90 |
| Cohort 4 (capecitabine, Y90) | Experimental | Drug: capecitabine, Radiation: yttrium Y 90 glass microspheres2,000 mg/m2 capecitabine = 170 Y90 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabineAlso: C14H15FN3O7, prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3. | Drug | Cohort 1 (capecitabine, Y90), Cohort 2 (capecitabine , Y90), Cohort 3 (capecitabine, Y90), Cohort 4 (capecitabine, Y90) |
| yttrium Y 90 glass microspheresThe amount of radioactivity required to deliver the desired dose to the liver is calculated using a formula. The dose depends on the cohort upon which the patient is enrolled. Y90 is administered during Cycle #2 on days 1-7. | Radiation | Cohort 1 (capecitabine, Y90), Cohort 2 (capecitabine , Y90), Cohort 3 (capecitabine, Y90), Cohort 4 (capecitabine, Y90) |
Primary outcome
Maximal tolerated dose of yttrium Y 90
Time frame: During treatment and any time up to 6 weeks post-treatment
Toxicity profile of yttrium Y 90
Time frame: During treatment and up to 30 days post-treatment
Toxicity will be defined as number of adverse events related to treatment experienced during treatment
Time to tumor progression
Time frame: At time of disease progression
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 9 Sep 2019.
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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.
Mary Mulcahy, MD principal investigator
Robert H. Lurie 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 capecitabine and yttrium Y 90 glass microspheres in people with Liver Cancer and Metastatic Cancer, run by Northwestern University 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?
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 9 Sep 2019. 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?
Maximal tolerated dose of yttrium Y 90 (time frame: During treatment and any time up to 6 weeks post-treatment). The study lists 3 primary outcomes in all. 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 9 Sep 2019.