A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Completed · Phase 2
Conditions studied: Pancreatic Adenocarcinoma
In brief
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.
Key facts
- Study ID
- NCT01839799
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 32
- Starts
- 2013-04-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2021-02-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients receiving any other investigational agents.
- Patients with known metastases.
- Patients with wounds that have not fully healed.
Where it is running
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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