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

Phase 2

Terminated

• Conditions: Pancreatic Neoplasms; Pancreatic Cancer
• Interventions: Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT01188109
• Lead Sponsor: Emory University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-06-30
• Results First Submitted QC: 2016-06-30
• Status Verified: 2016-08
• Results First Posted: 2016-08-09
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine / Cisplatin	Gemcitabine	Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Gemcitabine / Cisplatin	Cisplatin	Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival as Measured by CT Scan	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.

Secondary Outcome Measures

Name	Time	Method
Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression	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.

Trial Locations

Locations (2)

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States