RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB - LAP 07

• Conditions: Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC classification) and not considered for curative resection after pluridisciplinary discussion.; MedDRA version: 9.1Level: LLTClassification code 10052747Term: Adenocarcinoma pancreas

• Registration Number: EUCTR2007-001174-81-FR
• Lead Sponsor: GERCOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-02
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

1. Age older than = 18
2. Patients with de novo locally advanced, histologically proven adenocarcinoma of the pancreas without distant metastases (stage III according to the UICC classification) and not considered for curative resection after pluridisciplinary discussion.
3. ECOG Performance Status = 2
4. Estimated life expectancy = 12 weeks
5. No prior radiotherapy nor chemotherapy for any reason
6. Signed informed consent form
7. Polynuclear neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and hemoglobin = 9 g/dL
8. Total bilirubin =1.5 N (N: upper limit of normal). In patients who have had a recent biliary drain and whose bilirubin is descending, a value of = 3 N (50 µmoles/L) is acceptable.
9. AST and ALT = 2.5 N, alkaline phosphatase = 5 N
10. Albumin = 25 g/L
11. Creatinin = 177 µmol/L (2 mg/dL)
12. Female patients who are not menopausal and their partners must accept to use effective contraception throughout treatment and for 3 months after the end of treatment. All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
2. Previous chemotherapy for any reason
3. Previous abdominal radiotherapy
4. Allergy to one of ingredients in erlotinib
5. Prior treatment with an anti-EGFR
6. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the uterus or basal cell skin cancer.
7. Severe infection
8. Ophthalmic disease (inflammation, keratopathy or infection)
9. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the last 6 months.
10. Unable to take oral treatments or with gastrointestinal disorders that could be associated with absorption disorders, untreated gastric or duodenal ulcer.
11. Pregnancy or breast feeding
12. Unable to follow for psychological, familial or geographic reasons.
13. Not affiliated with a social security regime.
14. Diarrhea = grade 2 and/or uncontrolled diarrhoea

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified