Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets
|ClinicalTrials.gov Identifier: NCT01581307|
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : January 6, 2017
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Pancreatic Cancer||Drug: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) Device: TheraSpheres||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2012|
|Primary Completion Date :||February 2016|
|Study Completion Date :||March 2016|
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 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)
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.
Other Names: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.
- Median Overall Survival (OS) [ Time Frame: Up to 29 months ]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.
- Rate of Progression Free Survival (PFS) [ Time Frame: Up to 29 months ]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.
- Overall Response Rate (ORR) [ Time Frame: Up to 29 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581307
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Sarah Hoffe, M.D.||H. Lee Moffitt Cancer Center and Research Institute|