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

Pancreatic Cancer Clinical Trial

Official title:

Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416662
• Other study ID #: CDR0000703689
• Secondary ID: FFCD-1004EU-2111
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2011
• Last updated: May 27, 2016
• Start date: June 2011
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
France	CHU de la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	capability of CDA to predict the occurrence of early severe hematological toxicity upon gemcitabine		2 months	Yes
Secondary	Overall Survival		2 years	No