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

NCT01581307 | Completed Phase 2 Results DMC

• 1 other identifier: MCC-16764
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Pancreatic Cancer

Keywords

liver; pancreas; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of Progression Free Survival (PFS)

  Up to 29 months

• Overall Response Rate (ORR)

  Up to 29 months

Study Arms (1)

2nd Line Chemotherapy With Radiotherapy

EXPERIMENTAL

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 two weeks for 6-10 cycles. The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.

Drug: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin); Device: TheraSpheres

Interventions

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

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.

Also known as: Leucovorin, LV, FOL, OX, 5-Fluorouracil (5-FU), FOLFOX, ELOXATIN

2nd Line Chemotherapy With Radiotherapy

TheraSpheres DEVICE

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.

Also known as: radiotherapy, radioembolization

2nd Line Chemotherapy With Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• BTG International Inc.: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Pancreatic Neoplasms

Interventions

Leucovorin; Fluorouracil; Oxaliplatin; Folfox protocol; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Dr. Sarah Hoffe
• Organization: H. Lee Moffitt Cancer Center and Research Institute

sarah.hoffe@moffitt.org

813-745-4380

Study Officials

• Sarah Hoffe, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 3, 2017
• Results First Posted: January 6, 2017

Record last verified: 2016-11

Locations

US (1)