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

Tracking Information
First Submitted Date  ICMJE August 12, 2011
First Posted Date  ICMJE August 15, 2011
Last Update Posted Date May 30, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2011)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
Overall Survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2011)
  • 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
  • Ability of CDA to predict the occurrence of severe hematological toxicity (grade 3 or 4) during all courses, induced by gemcitabine hydrochloride
  • Impact of CDA status on gemcitabine hydrochloride pharmacokinetics and the ratio of gemcitabine hydrochloride/dFdU metabolization
  • Genotype to phenotype study of the CDA gene
  • New mutations on the CDA gene
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Official Title  ICMJE Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas
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.

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: gemcitabine hydrochloride
Study Arms  ICMJE gemcitabine
gemcitabine
Intervention: Drug: gemcitabine hydrochloride
Publications * Serdjebi C, Gagnière J, Desramé J, Fein F, Guimbaud R, François E, André T, Seitz JF, Montérymard C, Arsene D, Volet J, Abakar-Mahamat A, Lecomte T, Guerin-Meyer V, Legoux JL, Deplanque G, Guillet P, Ciccolini J, Lepage C, Dahan L. FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients. PLoS One. 2015 Aug 26;10(8):e0135907. doi: 10.1371/journal.pone.0135907. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No chemotherapy or radiotherapy within the past 10 years
  • No prior ablation surgery leaving macroscopic tumor residues (R2)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416662
Other Study ID Numbers  ICMJE CDR0000703689
FFCD-1004
EU-21118
EUDRACT-2010-022987-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Federation Francophone de Cancerologie Digestive
Study Sponsor  ICMJE Federation Francophone de Cancerologie Digestive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laetitia Dahan, MD CHU de la Timone
PRS Account Federation Francophone de Cancerologie Digestive
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP