Clinical trial NCT01581307: Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Pancreatic Cancer
Keywords: liver
pancreas
chemotherapy
radiotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: BTG International Inc.
First posted: 2012-04-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and impact on survival with treatment with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory metastatic pancreatic cancer with predominantly liver metastases.


Eligibility criteria: 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 2
* 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

Primary outcomes:
measure: Median Overall Survival (OS)
timeFrame: Up to 29 months
Secondary outcomes:
measure: Rate of Progression Free Survival (PFS)
timeFrame: Up to 29 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 29 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Sarah Hoffe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: