Status:
COMPLETED
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.
Detailed Description
This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemothe...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
- Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
- Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
- Age \> 18 years.
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:
- Absolute Neutrophil Count (ANC) \> 1,500/µL Platelets \> 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)\<2.5X institutional upper limit of normal Creatinine clearance \> 60mL/min for patients with creatinine levels above institutional normal.
- Patients must be \> 4 weeks and \< 12 weeks post-surgery at time of study registration.
- Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
- Women must not be pregnant or breast-feeding.
Exclusion
- Patients receiving any other investigational agents.
- Patients with known metastases.
- Patients with wounds that have not fully healed.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01839799
Start Date
April 1 2013
End Date
July 1 2017
Last Update
February 25 2021
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104