Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Conditions
Pancreatic Neoplasms - Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic Neoplasms, Pancreatic cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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 chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.

The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.
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 after resection.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Adults (≥ 18 years) at the time of signing informed consent form

2. Understand and voluntarily sign informed consent form

3. Able to adhere to study visit schedule and other protocol requirements

4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

5. Absolute neutrophil count ≥ 1500 / mm³

6. Platelet count ≥ 100,000 / mm³

7. Resectable pancreatic adenocarcinoma

8. Pathologic diagnosis of pancreatic adenocarcinoma

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form

2. A history of renal dysfunction (Serum Creatinine > 1.8 mg/dL)

3. Presence of active infection

4. Untreated second malignancy

5. 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.)
Locations
Emory University Hospital Midtown
Atlanta, Georgia, United States
Status: Recruiting
Contact: Penny Decker - 404-778-2670 - penny.decker@emory.edu
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Status: Recruiting
Contact: Penny Decker - 404-778-2670 - penny.decker@emory.edu
Start Date
July 2010
Completion Date
August 2016
Sponsors
Emory University
Source
Emory University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page