NCT01188109

Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Neoplasms
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days
DRUG	Cisplatin	Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2010-08-25
• Last updated: 2016-09-28
• Results posted: 2016-08-09

Locations

2 sites across 1 country: United States