Clinical trialPhase 2Terminated
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
- Outcome
- Stopped earlySlow accrual (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2010
- Expected end
- July 2015
- Enrollment
- 25 participants
- Sites
- 2
- Primary outcomes
- Recurrence-free Survival as Measured by CT Scan
- Sponsor
- Other
- Results posted
- 2016-08-09
- Last update
- 28 September 2016
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Recurrence-free Survival as Measured by CT Scan [Every 3 months and then every 6 months for 2 more years after resection]. Median, months (95% Confidence Interval). Gemcitabine / Cisplatin (n=22): 16.7 (6.9 to 26.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression [At the time of resection]. Number, patients. Low Tumor ERCC1 Expression: Gemcitabine / Cisplatin (n=20): 15. High Tumor ERCC1 Expression: Gemcitabine / Cisplatin (n=20): 5.