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

Phase 1

• Conditions: locally advanced non-metastatic pancreatic cancer

• Registration Number: EUCTR2005-004519-32-AT
• Lead Sponsor: Medical University Vienna, Dept. of surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-24
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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
9.Histologically or cytologically documented pancreatic cancer (adenocarcinoma) staged T4 (stage III) according to the 6th edition of the TNM classification

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. 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
11.Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
12.Inability to take oral medication, prior surgical procedures affecting absorption or resulting in the requirement for iv alimentation or parenteral nutrition with lipids, and/or active peptic ulcer disease
13.Pregnant or lactating females; serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start
14.Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
15.Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
16.Known hypersensitivity to any of the study drugs
17.Unwilling or unable to comply with the protocol for the duration of the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary endpoint of the study is to evaluate the complete tumour resection rate (R0) after four cycles of neoadjuvant chemotherapy with gemcitabine and bevacizumab in patients with locally advanced, non- metastatic pancreatic carcinoma.;Secondary Objective: • To evaluate the perioperative complication rate after neodjuvant chemotherapy<br>• To evaluate the safety and feasibility of the regimens used<br>• To evaluate the overall survival for the patient population<br>;Primary end point(s):