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A Phase II Clinical Trial Evaluating Overall Survival With Therasphere® In Conjunction With 2nd-Line FOLFOX In Patients With Gemcitabine-Refractory Pancreatic Carcinoma With Liver Metastases

Phase 2
18 Years
Open (Enrolling)
Liver Cancer, Pancreatic Cancer

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Trial Information

A Phase II Clinical Trial Evaluating Overall Survival With Therasphere® In Conjunction With 2nd-Line FOLFOX In Patients With Gemcitabine-Refractory Pancreatic Carcinoma With Liver Metastases

Inclusion Criteria:

- Patients must have metastatic pancreatic cancer with predominantly liver metastatic
disease (> 50%), as determined by the principal investigator (PI0 and referring
medical oncologist that have progressed on gemcitabine-based chemotherapy.

- Patients can have solitary, multifocal unilobar, or bilobar disease.

- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to

- No prior radiation or embolization of the liver

- Childs-Pugh score ≤ 7

- Lung shunting that predicts lung dose to be ≤ 30 Gy in a single treatment

- The effects of TheraSpheres on the developing human fetus at the recommended
therapeutic dose are unknown. For this reason and because radioactive spheres are
known to be teratogenic, women of child-bearing potential and men must agree to use
adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent document

- Adequate baseline hematopoietic function:

- total white blood cell count equal to or greater than 3,000/mm^3

- absolute granulocyte count greater than 1,500/mm^3

- platelet count equal to or greater than 50,000/mm^3

- Hemoglobin > 8.0

Exclusion Criteria:

- Patients currently receiving any other investigational agents

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because TheraSpheres are radioactive and
radiation is a known agent with the potential for teratogenic or abortifacient
effects. Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with TheraSpheres, breastfeeding should
be discontinued if the mother is treated with TheraSpheres.

- Initiation of second-line chemotherapy not consisting of FOLFOX

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy. In addition, antiretrovirals are known
radiation sensitizers and could dramatically increase the risk of fulminant hepatic
failure. Therefore, human immunodeficiency virus(HIV)-positive patients are excluded
from the study because of possible lethal side effects.

- Bulk disease (tumor volume > 70% of the target liver volume)

- Aspartic transaminase (AST) or alanine transaminase (ALT) > 5 times upper limit of
normal (ULN)

- Bilirubin > 2 mg/dL

- Child-Pugh score > 7

- Tumor volume > 50% of liver combined with an albumin < 3 g/dL

- Complete occlusion of main portal vein causing portal hypertension

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Overall Survival (OS)

Outcome Description:

OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.

Outcome Time Frame:

Average of 9 months

Safety Issue:


Principal Investigator

Ravi Shridhar, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

November 2016

Related Keywords:

  • Liver Cancer
  • Pancreatic Cancer
  • liver
  • pancreas
  • chemotherapy
  • radiotherapy
  • Liver Neoplasms
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612