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Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)


- To compare progression-free survival, overall survival, radiological response, and
safety and tolerability of cediranib maleate in combination with gefitinib versus
cediranib maleate in combination with a placebo in patients with recurrent or
progressive glioblastoma following standard front-line treatment.

OUTLINE: This is a multicenter study.

Patients receive cediranib maleate and gefitinib or cediranib maleate and a placebo once
daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity.

Blood and tissue samples are collected from some patients for genetic profiling and
biomarker analysis.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Inclusion Criteria


- Histologically or cytologically confirmed glioblastoma

- Measurable disease by MRI

- Completed standard first-line treatment for glioblastoma including surgery (unless
not received due to anatomical location), radiotherapy and temozolomide (last dose
given at least 28 days prior to enrollment)

- No other prior treatment for glioblastoma except Gliadel or steroids

- Recurrent or progressive disease after standard first-line treatment

- No disease progression within 3 months of completion of radiotherapy

- No intra- or peri-tumoral hemorrhage


- Karnofsky performance status 70-100%

- Mini-mental status score ≥ 15

- Life expectancy ≥ 12 weeks

- Serum bilirubin, ALT/AST, creatinine, and urine protein normal

- Adequate bone marrow reserve

- Not pregnant or nursing

- Normal ECG

- No history of familial long QT syndrome

- No absorption or swallowing difficulties

- No uncontrolled hypertension or cardiac ventricular arrhythmias

- No current or history of uncontrolled hypertension or requiring maximal doses of
calcium channel blockers

- No severe or uncontrolled disease

- No history of lung disease

- No recent hemorrhage or hemoptysis

- No known hypersensitivity to cediranib maleate, gefitinib, or any excipients

- No history of other malignancies except adequately treated basal cell or squamous
cell carcinoma or carcinoma in situ within the past 5 years, unless disease-free for
2 years with tissue diagnosis

- No known HIV positivity

- No known hepatitis B or C infection

- No unhealed surgical incision

- Not involved in planning or conducting this study


- See Disease Characteristics

- Recovered from prior anticancer therapy, including radiotherapy

- At least 3 months since prior cranial radiation

- At least 30 days since prior investigational drugs

- At least 28 days since prior craniotomy

- At least 2 weeks since prior enzyme-inducing antiepileptic drugs

- At least 2 weeks since prior and no concurrent dexamethasone (> 8 mg/day) or

- At least 14 days since prior major surgery or brain biopsy

- No concurrent steroids OR on stable dose 5 days prior to baseline MRI

- No other concurrent anticancer therapy, except for steroids (dexamethasone only)

- No previous enrollment on the current study

- No prior inhibitors of angiogenesis, EGFR, or downstream targets

- No prior radiosurgery or brachytherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

from the date of randomisation to the date of first progression or death due to any cause

Safety Issue:


Principal Investigator

Paul Mulholland, PhD, MRCP, MSC, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2011

Completion Date:

November 2013

Related Keywords:

  • Glioblastoma
  • adult giant cell glioblastoma
  • adult glioblastoma
  • adult gliosarcoma
  • recurrent adult brain tumor
  • Glioblastoma