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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms, Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival and overall survival as measured by CT scan every 3 months and clinical follow-up

Outcome Time Frame:

every 3 months

Safety Issue:

No

Principal Investigator

Shishir Maithel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WCI1738-09

NCT ID:

NCT01188109

Start Date:

July 2010

Completion Date:

August 2014

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pancreatic cancer
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322