Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IA pancreatic cancer, stage IB pancreatic cancer, stage IIA pancreatic cancer
Eligibility Criteria
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)
Sites / Locations
- CHU de la Timone
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
gemcitabine
Arm Description
gemcitabine
Outcomes
Primary Outcome Measures
capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine
Secondary Outcome Measures
Overall Survival
Full Information
NCT ID
NCT01416662
First Posted
August 12, 2011
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT01416662
Brief Title
Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Official Title
Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IA pancreatic cancer, stage IB pancreatic cancer, stage IIA pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gemcitabine
Arm Type
Other
Arm Description
gemcitabine
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laetitia Dahan, MD
Organizational Affiliation
CHU de la Timone
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26308942
Citation
Serdjebi C, Gagniere J, Desrame J, Fein F, Guimbaud R, Francois E, Andre T, Seitz JF, Monterymard 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.
Results Reference
result
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Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
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