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

Federation Francophone de Cancerologie Digestive

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT01416662

EUDRACT-2010-022987-11

EU-21118

CDR0000703689

FFCD-1004

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)