Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
This study is currently recruiting participants.
Verified April 2011 by Northwestern University
Sponsor:
Northwestern University
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00858429
First received: March 6, 2009
Last updated: April 15, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Metastatic Cancer |
Drug: capecitabine Radiation: yttrium Y 90 glass microspheres |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver |
Resource links provided by NLM:
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine
Methamphetamine
Yttrium
Capecitabine
U.S. FDA Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Maximal tolerated dose of yttrium Y 90 [ Time Frame: During treatment and any time up to 6 weeks post-treatment ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: During treatment and up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Time to tumor progression [ Time Frame: At time of disease progression ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: capecitabine
- 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.
Other Names:
Radiation: yttrium Y 90 glass microspheres
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858429
Contacts
| Contact: Mary Mulcahy, MD | 312-695-4440 | m-mulcahy@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Study Coordinator 312-695-1301 cancertrials@northwestern.edu | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mary Mulcahy, MD, Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00858429 History of Changes |
| Other Study ID Numbers: | NU 08I5, NU-08I5, STU00007062 |
| Study First Received: | March 6, 2009 |
| Last Updated: | April 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
advanced adult primary liver cancer liver metastases adult primary cholangiocellular carcinoma |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Neoplastic Processes Pathologic Processes Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Doxifluridine Fluorouracil Capecitabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013