Status:
COMPLETED
Gemcitabine Hydrochloride in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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...
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 ge...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01416662
Start Date
June 1 2011
End Date
September 1 2015
Last Update
May 30 2016
Active Locations (1)
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1
CHU de la Timone
Marseille, France, 13385