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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01188109
• Other study ID #: IRB00034258
• Secondary ID: WCI1738-09
• Status: Terminated
• Phase: Phase 2
• First received: July 23, 2010
• Last updated: August 5, 2015
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine
Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days
• Cisplatin
Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival and overall survival as measured by CT scan every 3 months and clinical follow-up.		every 3 months	No
Secondary	Immunohistochemistry, real time polymerase chain reaction (RT-PCR), and single nucleotide polymorphism assessment to determine status of Excision Repair Cross Complementation Gene-1 (ERCC1) expression and gene.		Tests will be run after 2 years from initiation of the trial. Patients will be followed until death.	No