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

NCT ID: NCT01416662

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Keywords

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adenocarcinoma of the pancreas stage IA pancreatic cancer stage IB pancreatic cancer stage IIA pancreatic cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gemcitabine

gemcitabine

Group Type OTHER

gemcitabine hydrochloride

Intervention Type DRUG

Interventions

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gemcitabine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laetitia Dahan, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Timone

Locations

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CHU de la Timone

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26308942 (View on PubMed)

Other Identifiers

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FFCD-1004

Identifier Type: -

Identifier Source: secondary_id

EU-21118

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2010-022987-11

Identifier Type: -

Identifier Source: secondary_id

CDR0000703689

Identifier Type: -

Identifier Source: org_study_id