Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Status: | Terminated |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | July 2010 |
End Date: | July 2015 |
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
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.
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.
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.
to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as
adjuvant therapy after resection.
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.)
We found this trial at
2
sites
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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