Status:
UNKNOWN
Proton w/FOLFIRINOX-Losartan for Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "I...
Detailed Description
If you are willing to participate in this research study, you will be asked to undergo some screening tests and procedures to confirm that you are eligible. Many of these tests and procedures are like...
Eligibility Criteria
Inclusion
- Cytologic or histologic proof pancreatic ductal carcinoma
- Locally advanced, unresectable disease
- Life expectancy of at least 3 months
Exclusion
- Evidence of metastatic disease
- Pregnant or breastfeeding
- Serious concomitant systemic disorders incompatible with the study
- Already treated on ACE or ARB therapy for hypertension or renal protection at the time of enrollment
- Baseline hypotension
- Prior chemotherapy, radiation therapy, or biologic therapy for treatment of pancreatic tumor
- Treatment for other invasive carcinomas within the last 5 years who are greater than 5% risk of recurrence at the time of eligibility screening (carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed)
- Other serious uncontrolled medical conditions
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing coagulopathy
- Prior systemic fluoropyrimidine therapy
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance or oral drug intake
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment
- Taking cimetidine
- Receiving other study agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-fluorouracil, irinotecan, oxaliplatin or losartan
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01821729
Start Date
July 1 2013
End Date
September 1 2021
Last Update
September 25 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114