Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX In Pancreatic Liver Mets

Study Overview

Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets

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.

N/A

Liver Cancer
Pancreatic Cancer

DRUG: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin)
DEVICE: TheraSpheres

MCC-16764

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-04-18	Results First Submitted 2016-11-09	Last Update Submitted that met QC Criteria 2017-01-20
First Submitted that Met QC Criteria 2012-04-19	Results First Submitted that Met QC Criteria 2016-11-09	Last Update Posted (ACTUAL) 2017-03-03
First Posted (ACTUAL) 2012-04-20	Results First Posted 2017-01-06	Last Verified 2016-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 2nd Line Chemotherapy With Radiotherapy Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every	DRUG: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment. DEVICE: TheraSpheres TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver throu

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 2nd Line Chemotherapy With Radiotherapy

Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first-line chemotherapy. Generally, second-line chemotherapy is given every

DRUG: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin)

The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.

DEVICE: TheraSpheres

TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver throu

Primary Outcome Measures	Measure Description	Time Frame
Median Overall Survival (OS)	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.	Up to 29 months

Secondary Outcome Measures	Measure Description	Time Frame
Rate of Progression Free Survival (PFS)	PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.	Up to 29 months
Overall Response Rate (ORR)	The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.	Up to 29 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

BTG International Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Sarah Hoffe, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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