Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer
NCT ID: NCT01713218
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
21 participants
INTERVENTIONAL
2012-12-31
2016-12-31
Brief Summary
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This proof-of-concept trial is studying the "dynamic" tumor response after the administration of a short course (4 weeks) neoadjuvant combination of gemcitabine and a Hedgehog inhibitor (Vismodegib) before surgery in patients with operable pancreatic cancer.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine+Vismodegib
Neoadjuvant chemotherapy combining gemcitabine and Vismodegib during 4 weeks before surgery
gemcitabine
Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, week 1 to 4
Vismodegib
150 mg capsule, oral, once daily
Neoadjuvant chemotherapy
Combination of gemcitabine and Vismodegib during a window interval (4 weeks) before surgery
Interventions
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gemcitabine
Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, week 1 to 4
Vismodegib
150 mg capsule, oral, once daily
Neoadjuvant chemotherapy
Combination of gemcitabine and Vismodegib during a window interval (4 weeks) before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Resectable or potentially resectable tumor; resectability assessed during a multidisciplinary meeting with expert surgeon and radiologist
* First line chemotherapy
* Age \> 18 years
* WHO performance status (PS) grade 0 or 1;
* Absolute neutrophil count \> 1.5 x 10 9 / L, platelets \> 100 x 10 9/ L, creatinine clearance (Cockcroft and Gault formula) \> 60 ml/min, haemoglobin level \> 10 g/dl (transfusions authorized), bilirubin\<1.5 g/dl;
* Optimal biliary drainage;
* Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study;
* Signed written informed consent.
Exclusion Criteria
* Previous anticancer therapy for the pancreatic adenocarcinoma
* Biliary obstruction without endoscopic biliary drainage
* Any contre-indication for surgery
* Prior malignancy (except non-melanoma skin cancer, and in situ carcinoma of the uterine cervix treated with a curative intent and any other tumor in complete remission with a disease-free interval \> 3 years)
* Uncontrolled congestive heart failure or angina pectoris, myocardial infarction within 1 year prior to study entry, uncontrolled hypertension (systolic pressure \> 160 mm or diastolic pressure \> 100 mm under well conducted antihypertensive treatment), QT prolongation
* Major uncontrolled infection
* Severe hepatic impairment
* Any medical, psychological, or social condition, which, in the opinion of the investigator, could hamper patient's compliance to the study protocol and/or assessment/interpretation of the data
* Pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods
* Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study;Subject previously enrolled into this study.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Jean-Luc Van Laethem
OTHER
Responsible Party
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Jean-Luc Van Laethem
MD, PhD
Principal Investigators
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Jean-Luc Van Laethem, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital
Locations
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Antwerp University Hospital (UZA)
Edegem, Antwerpen, Belgium
Erasme University Hospital (ULB)
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Marc Peeters, MD,PhD
Role: primary
Jean-Luc Van Laethem, MD, PhD
Role: primary
Other Identifiers
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2012-003516-31
Identifier Type: -
Identifier Source: org_study_id