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

NCT01601808 | Completed Phase 2 DMC

• 2 other identifiers: 2010-021951-2674555382
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 14

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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

  Analysis will be carried out when all patients have a minimum of 1-year follow-up after randomisation

Secondary Outcomes (5)

• 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

Study Arms (2)

Gemcitabine and Placebo

PLACEBO COMPARATOR

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

Gemcitabine and vandetanib

EXPERIMENTAL

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)

Interventions

Placebo DRUG

Orally once a day, continuously throughout the study

Gemcitabine and Placebo

Caprelsa (vandetanib) DRUG

Orally once a daily, continuously throughout the study.

Gemcitabine and vandetanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead
• AstraZeneca: collaborator

Study Sites (14)

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

The Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Clatterbridge Centre for Oncology

Liverpool, CH63 4JY, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L69 3GA, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Guys & St Thomas Hospital

London, SE1 9RT, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Dr Gary Middleton

  Royal Surrey County Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: May 18, 2012
• Study Start: October 10, 2011
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: March 13, 2025

Record last verified: 2012-05

Locations

GB (14)