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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581307
First Posted: April 20, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
Results First Submitted: November 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Liver Cancer
Pancreatic Cancer
Interventions: Drug: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin)
Device: TheraSpheres

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at Moffitt Cancer Center June 2012 through March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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.

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.

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.


Participant Flow:   Overall Study
    2nd Line Chemotherapy With Radiotherapy
STARTED   9 
COMPLETED   8 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants. Outcome Measures may reference participants evaluable at time of analysis.

Reporting Groups
  Description
2nd Line Chemotherapy With Radiotherapy Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.

Baseline Measures
   2nd Line Chemotherapy With Radiotherapy 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  44.4% 
>=65 years      5  55.6% 
Age 
[Units: Years]
Median (Full Range)
 70.44 
 (57 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  55.6% 
Male      4  44.4% 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Overall Survival (OS)   [ Time Frame: Up to 29 months ]

2.  Secondary:   Rate of Progression Free Survival (PFS)   [ Time Frame: Up to 29 months ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Up to 29 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sarah Hoffe
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-4380
e-mail: sarah.hoffe@moffitt.org



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01581307     History of Changes
Other Study ID Numbers: MCC-16764
First Submitted: April 18, 2012
First Posted: April 20, 2012
Results First Submitted: November 9, 2016
Results First Posted: January 6, 2017
Last Update Posted: March 3, 2017