ViP: Clinical Trial Comparing Gemcitabine and Vandetanib Therapy With Gemcitabine Alone in Pancreatic Carcinoma

Sponsor

University of Liverpool (Other)

Overall Status

Unknown status

CT.gov ID

NCT01601808

Collaborator

AstraZeneca (Industry)

120

Enrollment

Locations

Arms

Duration (Months)

8.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ViP is a double blinded clinical trial which will compare gemcitabine and vandetanib chemotherapy with gemcitabine alone in patients with locally advanced or metastatic pancreatic carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Placebo Drug: Caprelsa (vandetanib)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Prospective, Phase II, Double Blinded, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Vandetanib Therapy With Gemcitabine Therapy Alone in Locally Advanced or Metastatic Pancreatic Carcinoma

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Gemcitabine and Placebo Standard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.	Drug: Placebo Orally once a day, continuously throughout the study
Experimental: Gemcitabine and vandetanib Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.	Drug: Caprelsa (vandetanib) Orally once a daily, continuously throughout the study.

Arm

Intervention/Treatment

Placebo Comparator: Gemcitabine and Placebo

Standard therapeutic arm. Placebo orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.

Drug: Placebo

Orally once a day, continuously throughout the study

Experimental: Gemcitabine and vandetanib

Experimental arm. Vandetanib orally once a day continuously together with gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 7 consecutive weeks. This will then be followed by a one week break and then gemcitabine 1000mg/m2 weekly as a 30 minute infusion for 3 weeks followed by a one week break in subsequent cycles.

Drug: Caprelsa (vandetanib)

Orally once a daily, continuously throughout the study.

Outcome Measures

Primary Outcome Measures

Overall survival [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]
To assess whether survival times for patients receiving gemcitabine plus vandetanib are longer than for those patients receiving gemcitabine alone as first line treatment for advanced pancreatic cancer

Secondary Outcome Measures

Progression-free survival time [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]
Objective response rate [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]
Disease control rate [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]
Number and types of adverse events [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]
Patient pain assessment [Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years.
Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.
Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected Pancreatic Cancer can be included.
Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment.
Unidimensionally measurable disease as shown by CT scan, in accordance with RECIST guidelines (version 1.1)
ECOG performance status 0, 1 or 2 where the investigator feels that treatment with combination chemotherapy.
Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry.
Documented Life expectancy > 3 months.
Informed written consent

Exclusion Criteria:

Laboratory results:
Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR).
Haemoglobin < 10G/dl
Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)**. Patients with a creatinine clearance of ≥30mL/minute and <50mL/minute should begin vandetanib on a reduced dose of 200mg.
Potassium, ≤4.0 mmol/L despite supplementation; or > 5.5 mmol/L
Magnesium below the normal range despite supplementation, or > 1.23 mmol/L
Serum calcium is > 2.9 mmol/L. In cases where serum calcium is below the normal range this can be substituted with the value for calcium adjusted for albumin, if this is below the normal range despite supplementation patients should be excluded.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) >2.5 x ULRR or > 5x ULRR if judged by the investigator to be related to liver metastases.
Medical or psychiatric conditions compromising informed consent.
Intracerebral metastases or meningeal carcinomatosis.
Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
Evidence of severe or uncontrolled systemic disease or any concurrent condition
Clinically significant cardiovascular eventclassification of heart disease ≥2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
QTc prolongation with other medications that required discontinuation of that medication.
Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
Presence of left bundle branch block (LBBB).
QTc with Bazett's correction that is un-measurable or ≥ 480 msec on screening ECG. Patients who are receiving a drug that has a risk of inducing Torsades-de-Pointes are excluded if QTc is ≥ 460 msec.
Any concurrent medication with a known risk of inducing Torsades-de-Pointes, that in the investigator's opinion cannot be discontinued, are allowed.
Concomitant medications that are potent inducers.
Hypertension not controlled by medical therapy.
Currently active diarrhoea.
Malabsorption syndrome.
Pregnancy or breast feeding.
Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously.
Radiotherapy within the last 4 weeks prior to start of study treatment.
Concurrent malignancies or invasive cancers diagnosed within past 5 years.
Chemotherapy directed at tumour apart from that described in this protocol.
All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Belfast City Hospital	Belfast	United Kingdom	BT9 7AB
2	The Royal Bournemouth Hospital	Bournemouth	United Kingdom	BH7 7DW
3	Bristol Haematology and Oncology Centre	Bristol	United Kingdom	BS2 8ED
4	Royal Surrey County Hospital	Guildford	United Kingdom	GU2 7XX
5	Clatterbridge Centre for Oncology	Liverpool	United Kingdom	CH63 4JY
6	Royal Liverpool University Hospital	Liverpool	United Kingdom	L69 3GA
7	St Bartholomew's Hospital	London	United Kingdom	EC1A 7BE
8	Guys & St Thomas Hospital	London	United Kingdom	SE1 9RT
9	Royal Marsden Hospital	London	United Kingdom	SW3 6JJ
10	The Christie Hospital	Manchester	United Kingdom	M20 4BX
11	James Cook University Hospital	Middlesbrough	United Kingdom	TS4 3BW
12	Freeman Hospital	Newcastle	United Kingdom	NE7 7DN
13	Nottingham City Hospital	Nottingham	United Kingdom	NG5 1PB
14	Weston Park Hospital	Sheffield	United Kingdom	S10 2SJ

Sponsors and Collaborators

University of Liverpool
AstraZeneca

Investigators

Principal Investigator: Dr Gary Middleton, Royal Surrey County Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Gary MIddleton, Consultant Medical Oncologist, University of Liverpool

ClinicalTrials.gov Identifier:

NCT01601808

Other Study ID Numbers:

2010-021951-26
74555382

First Posted:

May 18, 2012

Last Update Posted:

May 18, 2012

Last Verified:

May 1, 2012

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of May 18, 2012