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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188109
Recruitment Status : Terminated (Slow accrual)
First Posted : August 25, 2010
Results First Posted : August 9, 2016
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
Shishir Kumar Maithel, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Pancreatic Cancer Drug: Gemcitabine Drug: Cisplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
Study Start Date : July 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
Drug: Gemcitabine

Standard of care chemotherapy and dosage

Dose - 1000 mg/m²

Schedule - Days 1 and 15; Q 28 days

Other Name: Gemzar

Drug: Cisplatin

Dose - 50 mg/m²

Schedule - Days 1 and 15; Q 28 days

Other Name: Platinol

Primary Outcome Measures :
  1. Recurrence-free Survival as Measured by CT Scan [ Time Frame: 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 :
  1. Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01188109

United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Shishir Maithel, MD Emory University Winship Cancer Institute

Responsible Party: Shishir Kumar Maithel, MD, Emory University Identifier: NCT01188109     History of Changes
Other Study ID Numbers: IRB00034258
WCI1738-09 ( Other Identifier: Other )
First Posted: August 25, 2010    Key Record Dates
Results First Posted: August 9, 2016
Last Update Posted: September 28, 2016
Last Verified: August 2016

Keywords provided by Shishir Kumar Maithel, Emory University:
Pancreatic Neoplasms
Pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents