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| ID | Type | Description | Link |
|---|---|---|---|
| NU-08I5 | |||
| STU00007062 | |||
| NCI-2009-01122 | Other Identifier | NCI CTRP# |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (capecitabine, Y90) | Experimental | 2,000mg/m2 capecitabine +110 Y90 |
|
| Cohort 2 (capecitabine , Y90) | Experimental | 2,000mg/m2 capecitabine + 130 Y90 |
|
| Cohort 3 (capecitabine, Y90) | Experimental | 2,000mg/m2 Capecitabine + 150 Y90 |
|
| Cohort 4 (capecitabine, Y90) | Experimental | 2,000 mg/m2 capecitabine = 170 Y90 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | 1000 mg/m2 twice daily, for 14 consecutive days followed by a 7 day treatment free rest period for cycles 1, 2 and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal tolerated dose of yttrium Y 90 | 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 | During treatment and up to 30 days post-treatment |
| Time to tumor progression | At time of disease progression |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Mulcahy, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| C025034 | doxifluridine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| yttrium Y 90 glass microspheres | Radiation | 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. |
|
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |