Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcino… (NCT00858429) | Clinical Trial Compass
CompletedPhase 1
Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
United States18 participantsStarted 2009-04-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 concurren…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal tolerated dose of yttrium Y 90
Timeframe: During treatment and any time up to 6 weeks post-treatment
2
Toxicity profile of yttrium Y 90
Timeframe: During treatment and up to 30 days post-treatment