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

This study is currently recruiting participants.
Verified May 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Shishir Kumar Maithel, Emory University
ClinicalTrials.gov Identifier:
NCT01188109
First received: July 23, 2010
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Neoplasms
Pancreatic Cancer
 Drug: Gemcitabine and cisplatin
Drug: Gemcitabine / Cisplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Progression free survival and overall survival as measured by CT scan every 3 months and clinical follow-up [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunohistochemistry, rt-PCR, and single nucleotide polymorphism assessment to determine status of Excision Repair Cross Complementation Gene-1 (ERCC1) expression and gene. [ Time Frame: Tests will be run after 2 years from initiation of the trial. Patients will be followed until death. ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine / Cisplatin
Single arm study. All patients will receive Gem / Cis as adjuvant therapy.
 Drug: Gemcitabine and cisplatin

Gemcitabine

Dose - 1000mg/m2

Schedule - Days 1 and 15; Q 28 days

Cisplatin

Dose - 50mg/m2

Schedule - Days 1 and 15; Q 28 days

Other Names:
  • Gemzar
  • Platinol
Drug: Gemcitabine / Cisplatin
Standard of care chemotherapy and dosage
Other Name: Gemzar

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188109

Contacts
Contact: Shishir Maithel, MD 1-888-946-7447 smaithe@emory.edu

Locations
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Shishir Maithel, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Shishir Kumar Maithel, MD, Emory University
ClinicalTrials.gov Identifier: NCT01188109     History of Changes
Other Study ID Numbers: WCI1738-09
Study First Received: July 23, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Pancreatic Neoplasms
Pancreatic cancer

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

ClinicalTrials.gov processed this record on May 21, 2013