Comparing a combination gemcitabine and Vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic Pancreatic carcinoma

Phase 2

Completed

• Conditions: pper gastro-intestinal cancer, pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN74555382
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-10
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age > 18 years
2. Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
3. 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.
4. Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment
5. Unidimensionally measurable disease as shown by CT scan, in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) guidelines (version 1.1).
6. ECOG performance status 0, 1 or 2 where the investigator feels that treatment with combination chemotherapy, for example FOLFIRINOX, is not appropriate
7. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at entry
8. Documented Life expectancy > 3 months
9. Informed written consent
10. Male and female participants

Exclusion Criteria

1. Laboratory results: Serum bilirubin >1.5x the upper limit of reference range (ULRR). Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula).
Potassium, <4.0 mmol/L despite supplementation; or above the CTCAE grade 1 upper limit. Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit. Serum corrected calcium above the CTCAE grade 1 upper limit. In cases where the serum calcium is below the normal range despite supplementation. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 ULRR or alkaline phosphatase (ALP) >2.5 x ULRR, or > 5x ULRR if judged by the investigator to be related to liver metastases.
2. Medical or psychiatric conditions compromising informed consent
3. Intracerebral metastases or meningeal carcinomatosis
4. Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy
5. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator?s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
6. Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification 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
7. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded
8. QTc prolongation with other medications that required discontinuation of that medication
9. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
10. Presence of left bundle branch block (LBBB)
11. QTc with Bazett?s correction that is un-measurable, or 480 msec on screening ECG
(Note: If a subject has a QTc interval 480 msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study.) Patients who are receiving a drug that has a risk of inducing Torsades-de-Pointes are excluded if QTc is = 460 msec.
12. Any concurrent medication with a known risk of inducing Torsades-de-Pointes, that in the investigator?s opinion cannot be discontinued, are allowed; however, these patients must be monitored closely (please see section 4.2).
13. Concomitant medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.
14. Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
15. Currently active diarrhoea that may affect the ability of the patient to absorb the vandetanib or tolerate diarrhoea secondary to vandetanib should that occur as a side effect.
16. Malabsorption syndrome which may impair the absorption of vandetanib (partial gastrectomy, small bowel resection), This may include previous partial gastrectomy and small bowel resection or active Crohn?s disease, ulcerative colitis.
17. Pregnancy or bre

Study & Design

• Study Type: Interventional
• Study Design: Not specified