Status:
COMPLETED
Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Er...
Detailed Description
OBJECTIVES: Primary * To assess whether administrating chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared with continua...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:
- De novo locally advanced disease
- Unresectable disease
- Stage III according to the UICC classification
- No distant metastases
- No localized stage IA-IIB or metastatic stage IV disease according to UICC classification
- Not considered for curative resection after pluridisciplinary discussion
- PATIENT CHARACTERISTICS:
- Inclusion criteria:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Polynuclear neutrophils ≥ 1.5 x 10\^9/L
- Platelets ≥ 100 x 10\^9/L
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable
- Creatinine ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Albumin ≥ 25 g/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of therapy
- Exclusion criteria:
- Diarrhea ≥ grade 2 and/or uncontrolled diarrhea
- Affiliated with a social security regime
- Unable to follow instructions for psychological, familial, or geographical reasons
- Allergic to one of the ingredients in erlotinib hydrochloride
- Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer
- Severe infection
- Ophthalmic disease (i.e., inflammation, keratopathy, or infection)
- Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months
- Unable to take oral treatments
- Gastrointestinal disorders that could be associated with absorption disorders
- Untreated gastric or duodenal ulcer
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason
- No prior anti-epidermal growth factor-receptor therapy
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00634725
Start Date
February 1 2008
End Date
September 1 2014
Last Update
December 11 2015
Active Locations (72)
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1
Centre Radiotherapie Oncologie Moyenne Garonne
Agen, France, 47000
2
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, France, 13616
3
Centre Paul Papin
Angers, France, 49036
4
Polyclinique Sainte Marguerite
Auxerre, France, 89000