Status:
TERMINATED
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Lead Sponsor:
Emory University
Conditions:
Pancreatic Neoplasms
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemothera...
Detailed Description
The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy af...
Eligibility Criteria
Inclusion
- Adults (≥ 18 years) at the time of signing informed consent form
- Understand and voluntarily sign informed consent form
- Able to adhere to study visit schedule and other protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Absolute neutrophil count ≥ 1500 / mm³
- Platelet count ≥ 100,000 / mm³
- Resectable pancreatic adenocarcinoma
- Pathologic diagnosis of pancreatic adenocarcinoma
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
- A history of renal dysfunction (serum creatinine \> 1.8 mg/dL)
- Presence of active infection
- Untreated second malignancy
- Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01188109
Start Date
July 1 2010
End Date
July 1 2015
Last Update
September 28 2016
Active Locations (2)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322