View Clinical Trial (Medical Research Study)
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1(ERCC1)in Treatment Decision
| City: |
|
Atlanta |
| State: |
|
Georgia |
| Zip Code: |
|
30322 |
| Conditions: |
|
Pancreatic Neoplasms - Pancreatic Cancer |
| Purpose: |
|
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.
|
| Study Summary: |
|
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: |
|
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. 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
|
| NCT ID: |
|
NCT01188109 |
| Primary Contact: |
|
Principal Investigator
Shishir Maithel, MD
Emory University Winship Cancer Institute
Shishir Maithel, MD
Phone: 1-888-946-7447
Email: smaithe@emory.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Atlanta, Georgia 30322
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 22, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|