Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases

NCT00858429 | Completed Phase 1 DMC

• 4 other identifiers: NU 08I5NU-08I5STU00007062NCI-2009-01122
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer; Metastatic Cancer

Keywords

advanced adult primary liver cancer; liver metastases; adult primary cholangiocellular carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Cohort 1 (capecitabine, Y90)

EXPERIMENTAL

2,000mg/m2 capecitabine +110 Y90

Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres

Cohort 2 (capecitabine , Y90)

EXPERIMENTAL

2,000mg/m2 capecitabine + 130 Y90

Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres

Cohort 3 (capecitabine, Y90)

EXPERIMENTAL

2,000mg/m2 Capecitabine + 150 Y90

Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres

Cohort 4 (capecitabine, Y90)

EXPERIMENTAL

2,000 mg/m2 capecitabine = 170 Y90

Drug: capecitabine; Radiation: yttrium Y 90 glass microspheres

Interventions

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.

Also known as: C14H15FN3O7, prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR)

Cohort 1 (capecitabine, Y90); Cohort 2 (capecitabine , Y90); Cohort 3 (capecitabine, Y90); Cohort 4 (capecitabine, Y90)

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.

Cohort 1 (capecitabine, Y90); Cohort 2 (capecitabine , Y90); Cohort 3 (capecitabine, Y90); Cohort 4 (capecitabine, Y90)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Interventions

Capecitabine; doxifluridine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mary Mulcahy, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: April 1, 2009
• Primary Completion: March 19, 2014
• Study Completion: July 8, 2014
• Last Updated: September 9, 2019

Record last verified: 2018-01

Locations

US (1)