Multi-centre, randomised, double-blind phase II study comparing cediranib (AZD2171) plus gefitinib (Iressa, ZD1839) with cediranib plus placebo in subjects with recurrent/progressive glioblastoma (DORIC Trial)

niversity College London (UK)0 sites38 target enrollmentMay 27, 2011

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity College London (UK)
Enrollment: 38
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27232884 results

Registry

who.int

Start Date

May 27, 2011

End Date

November 24, 2012

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity College London (UK)

Eligibility Criteria

Inclusion Criteria

•1\. Provision of informed consent
•2\. Age \=18 years
•3\. Life expectancy \= 12 weeks
•4\. Histological/cytological confirmation of glioblastoma (WHO grade IV)
•5\. Patients with measurable disease (contrast\-enhancing tumour \=10 mm by shortest diameter on 2 axial slices) by MRI imaging within 7 days prior to enrolment. (If patients have recently had a routine MRI scan, this should be assessed before deciding whether or not to screen the patient, and booking the screening/baseline MRI.)
•6\. Patients must have been on no steroids or a stable dose of steroids (dexamethasone) for at least 5 days before the baseline MRI
•7\. Patients must have completed standard first\-line treatment for glioblastoma including surgery (with exception, if patient does not receive surgery as part of first\-line treatment due to anatomical location, based on neurosurgeon's assessment), cranial radiotherapy and chemotherapy with concomitant temozolomide
•7\.1\. It is not essential that the entire Stupp regimen of 6 cycles of adjuvant temozolomide following chemoradiotherapy has been completed
•7\.2\. The last dose of temozolomide must be more than 28 days from enrolment
•7\.3\. Gliadel® wafers are permitted, as it is part of local treatment

Exclusion Criteria

•1\. Patients on enzyme\-inducing anti\-epileptic drugs within 2 weeks prior to study enrolment
•Note: Patients are eligible if they switched to non\-enzyme inducing agents and discontinued enzyme\-inducing agents for more than or equal to 2 weeks prior to randomisation
•2\. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count \=1\.5 x 109 /L or platelet count \=100 x 109 /L or requiring regular blood transfusions to maintain haemoglobin \>9g/dL
•3\. Serum bilirubin \=1\.5 x ULRR (except for patients with known documented cases of Gilbert?s Syndrome)
•4\. ALT or AST \=5 x ULRR
•5\. Serum creatinine \>1\.5 x ULRR or a creatinine clearance of \=50mL/min calculated by Cockcroft\-Gault
•6\. Greater than \+1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein \<1\.5g in a 24 hr period or UPC (Urine Protein: Creatinine) ratio \<1\.5
•7\. History of significant gastrointestinal impairment, as judged by the investigator, that would significantly affect the absorption of cediranib or gefitinib, including the ability to swallow the tablet whole
•8\. Patients with a history of poorly controlled hypertension with resting blood pressure \>150/100mmHg in the presence or absence of a stable regimen of anti\-hypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilise blood pressure
•9\. Any evidence of severe or uncontrolled diseases (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)