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Health Condition(s) or Problem
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Glioblastoma
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Lay Summary
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http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-cediranib-with-without-gefitinib-for-type-brain-tumour-glioblastoma-doric (from ISRCTN)
Additional lay summaries...
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.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- 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
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What will happen
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Drug; cediranib maleate; Cediranib & Gefitinib; Cediranbib & placebo; Drug; gefitinib; Cediranib & Gefitinib; Drug; Placebo; Cediranbib & placebo
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Primary aim
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Progression-free survival
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Secondary Aim
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Overall survival; from date of randomization to date of Death due to any cause.; No; Radiographic response rate; from baseline scan to six week and 12 week scans; No; Progression-free survival rate at 6 months; from the date of randomisation to 6 months; No; Steroid use; from randomization to first increase in dexamethasone dose; No; 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.; No; Safety and tolerability; from date of randomisation to death; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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London, Birmingham, Bristol, Cambridge, Guildford, Hull, Manchester, Southampton, Sutton
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