Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
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|ClinicalTrials.gov Identifier: NCT01188109|
Recruitment Status : Terminated (Slow accrual)
First Posted : August 25, 2010
Results First Posted : August 9, 2016
Last Update Posted : September 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Pancreatic Cancer||Drug: Gemcitabine Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days
Other Name: GemzarDrug: Cisplatin
Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days
Other Name: Platinol
- Recurrence-free Survival as Measured by CT Scan [ Time Frame: Every 3 months and then every 6 months for 2 more years after resection ]Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.
- Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression [ Time Frame: At the time of resection ]To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1-10%; 2 = 11-50%; 3 = 51-100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188109
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Shishir Maithel, MD||Emory University Winship Cancer Institute|