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Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery

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: NCT01416662
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : May 30, 2016
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Brief Summary:

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Phase 2

Detailed Description:



  • To determine the ability of cytidine deaminase (CDA) to predict the occurrence of early (during the first 2 courses) severe hematological toxicity (grade 3 or 4), induced by gemcitabine hydrochloride in patients with resected pancreatic adenocarcinoma.


  • To determine the ability of CDA to predict the occurrence of severe non-hematological toxicity (grade 3 or 4), early (during the first 2 courses), and during the following courses, induced by gemcitabine hydrochloride.
  • To determine the ability of CDA to predict the occurrence of severe hematological toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride.
  • To determine the impact of CDA status on gemcitabine hydrochloride pharmacokinetics and the ratio of gemcitabine hydrochloride/dFdU metabolization.
  • To study genotype to phenotype of the CDA gene.
  • To identify new mutations on the CDA gene.
  • To evaluate the relationship between CDA status and global survival. (Exploratory)

OUTLINE: This is a multicenter study.

Within 8 weeks of resection, patients receive adjuvant gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacogenetic and biomarker studies. Some patients may undergo blood sample collection for pharmacokinetic studies.

After completion of study, patients are followed up periodically.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas
Study Start Date : June 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Drug: gemcitabine hydrochloride

Primary Outcome Measures :
  1. capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

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.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the pancreas

    • No metastatic or locally advanced (nonresectable) disease
  • Must have undergone curative surgical resection

    • Must have macroscopically complete (R0 or R1) surgical outcome
  • Adjuvant treatment with gemcitabine hydrochloride (for 6 months) is necessary, and able to start treatment within 8 weeks of surgical resection
  • No ampullomas or endocrine carcinomas


  • WHO performance status 0-2
  • Neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Alkaline phosphatases ≤ 5 times upper limit of normal
  • Total bilirubin ≤ 50 µmol/L
  • Creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Able to start adjuvant chemotherapy within 8 weeks of surgery
  • No evolving infectious syndrome (fever > 38°C or abscess)
  • No contraindication for gemcitabine hydrochloride
  • No prior malignant tumor except for cutaneous basocellular carcinoma or in situ cervical epithelioma (prior history of malignant tumor diagnosed and treated more than 10 years ago allowed, except for breast cancer and melanoma)


  • See Disease Characteristics
  • No chemotherapy or radiotherapy within the past 10 years
  • No prior ablation surgery leaving macroscopic tumor residues (R2)

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): NCT01416662

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CHU de la Timone
Marseille, France, 13385
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
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Principal Investigator: Laetitia Dahan, MD CHU de la Timone
Publications of Results:
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Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT01416662    
Other Study ID Numbers: CDR0000703689
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: May 2016
Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the pancreas
stage IA pancreatic cancer
stage IB pancreatic cancer
stage IIA pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs