Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma | Stopped
Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Glioblastoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma. PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.
Research Details
  • OBJECTIVES: - 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.
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : cediranib maleate, Drug : gefitinib, Drug : Placebo

Study Arm Groups : Cediranib & Gefitinib, Cediranbib & placebo, Cediranib & Gefitinib, Cediranbib & placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-free survival; from the date of randomisation to the date of first progression or death due to any cause
Secondary Outcome Measures
  • Overall survival; from date of randomization to date of Death due to any cause.; Radiographic response rate; from baseline scan to six week and 12 week scans; Progression-free survival rate at 6 months; from the date of randomisation to 6 months; Steroid use; from randomization to first increase in dexamethasone dose; Time to deterioration of neurological status; from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.; Safety and tolerability; from date of randomisation to death
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Sorry, this information is not available
Participant 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
  • equivalent
  • - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
University College London
Research Site
Bristol Royal Hospital
Southampton General Hospital
Investigational Site 7006
Sanofi-Aventis Administrative Office
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
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)
EudraCT Number
Not available for this trial
  • AstraZeneca
Other Study ID Numbers
University College, London
Key Dates

Recruitment Start Date

May 2011

Recruitment End Date

May 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

05 Mar 2011

Last Updated

03 Jul 2014