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TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis

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Trial Information

TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer


Inclusion Criteria:



- 18 years of age or older

- diagnosis of metastatic disease to the liver that is refractory to, or inappropriate
for, other systemic or liver-directed therapies

- unresectable liver metastases

- target tumors measurable using standard imaging techniques

- tumor replacement < or = 50% of total liver volume (visual estimation by
investigator)

- Hypervascular tumors (visual estimation by investigator)

- ECOG 0 - 2

- minimum one month since most recent prior cancer therapy with the exception of
patients receiving Sandostatin for neuroendocrine cancer

- patient informed consent

Exclusion Criteria:

- At risk of hepatic or renal failure within 21 days of treatment (serum creatinine >
2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any
history of hepatic encephalopathy)

- contraindications to angiography and selective visceral catheterization including any
non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular
disease or history of non-management allergy or intolerance to contrast, narcotics,
sedatives or atropine

- severe liver dysfunction or presentation of pulmonary insufficiency or clinically
evident history of chronic obstructive pulmonary disease

- cirrhosis or portal hypertension

- prior external beam radiation treatment to the liver

- prior TheraSphere treatment to the liver

- any intervention for, or compromise of the Ampulla of Vater

- clinically evident ascites (trace ascites on imaging is acceptable)

- any continuing complications of prior cancer therapy that have not improved or
resolved prior to 21 days before first TheraSphere treatment

- significant life-threatening extrahepatic disease in judgment of physician

- concurrent enrollment in another study

- alternative available therapies in judgement of physician

- evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30
Gy cumulative limit

- evidence on technetium-99m macroaggregated albumin scan showing potential for
deposition of microspheres to the gastrointestinal tract that cannot be eliminated by
catheter placement or corrective action using standard angiographic techniques

- positive serum pregnancy test in women of childbearing potential

- co-morbid disease or condition that puts the patient at undue risk or precludes use
of TheraSphere in judgment of physician

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Liver progression-free survival according to RECIST criteria

Outcome Time Frame:

open-ended

Safety Issue:

No

Principal Investigator

Al Benson III, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

G040148

NCT ID:

NCT00511862

Start Date:

January 2007

Completion Date:

March 2011

Related Keywords:

  • Colorectal Cancer
  • Carcinoma, Neuroendocrine
  • Neoplasm Metastasis
  • TheraSphere
  • radioactive microspheres
  • Yttrium-90
  • Yttrium glass microspheres
  • Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Carcinoma, Neuroendocrine
  • Liver Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Albany Medical CenterAlbany, New York  12208
Northwestern Memorial Hospital, Robert H Lurie Comprehensive Cancer CenterChicago, Illinois  60611-2927
John Hopkins HospitalBaltimore, Maryland  21287-4010
Medical College of Wisconsin, Froedtert HospitalMilwaukee, Wisconsin  53226