A randomised controlled pilot study of the efficacy of adding bevacizumab to gemcitabine as neoadjuvant treatment for locally advanced non metastatic pancreatic cancer - Neo-Avastin

Medical University Vienna, Dept. of surgery0 sites20 target enrollmentOctober 24, 2005

Conditionslocally advanced non-metastatic pancreatic cancer

DrugsAvastin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: locally advanced non-metastatic pancreatic cancer
Sponsor: Medical University Vienna, Dept. of surgery
Enrollment: 20
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 24, 2005

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medical University Vienna, Dept. of surgery

Eligibility Criteria

Inclusion Criteria

•1\.Have provided written informed consent prior to study\-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
•2\.Age \= 18 years
•3\.Karnofsky Performance Status (KPS) \= 60
•4\.Life expectancy \= 8 weeks
•5\.Absolute neutrophil count \= 1500/mm3
•6\.Adequate liver function:
•\-Serum (total) bilirubin \= 1\.5 x ULN, AST \& ALT \= 2\.5 x ULN, Albumin \= 2\.5 g/dl.
•\-Alk Phos \= 2\.5 ULN. If Alk Phos is \> 2\.5 ULN, SGOT (AST) and SGPT (ALT) must be \= 1\.5 ULN.
•7\.Creatinine levels \= 2mg/dl (positive urine protein dipstick of \= 2\+ at baseline must have \= 1 g/24 hr protein)
•8\.Negative pregnancy test

Exclusion Criteria

•1\. Early (Stage IA to IIB) pancreatic cancer and metastatic (Stage IV) pancreatic cancer (as defined in Appendix 2\)
•2\.Previous systemic therapy for pancreatic cancer
•3\.Other primary tumour (including primary brain tumours) within the last 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer
•4\.CT\-scan based evidence of tumour invading major blood vessels (putting patients at risk of bleeding during trial treatment)
•5\.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgery during the course of the study treatment
•6\.Current or recent (within 10 days of Is' dose of study treatment) chronic use of aspirin (\>325 mg/day)
•7\.Current or recent (within 10 days of Is' dose of study treatment) chronic use of full therapeutic dose of oral or parenteral anticoagulants or thrombolytic agents
•8\.Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (\< 6 months prior to randomisation), myocardial infarction (\< 6 months prior to randomisation), unstable angina, New York Heart Association NYHA (Appendix 3\) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
•9\.History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
•10\.Non\-healing wound, ulcer, or bone fracture, patients with oesophageal varices