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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581307
• Other study ID #: MCC-16764
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: August 17, 2016
• Start date: April 2012
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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 through the blood vessels supplying the liver. TheraSpheres have restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but has not yet been approved for the treatment of pancreatic cancer that has spread to the liver.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 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.	Average of 9 months	No
Secondary	Number of Participants With 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.	Average of 9 months	No
Secondary	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.	Average of 9 months	No

External Links

•   Moffitt Cancer Center Clinical Trials website