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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00245154
Registration number
NCT00245154
Ethics application status
Date submitted
25/10/2005
Date registered
27/10/2005
Date last updated
4/08/2023
Titles & IDs
Public title
Paclitaxel + Carboplatin With/Out Cediranib Maleate in Stage III or Stage IV Non-Small Cell Lung Cancer
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Scientific title
A Phase II/III Double Blind Randomized Trial of AZD2171 Versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
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Secondary ID [1]
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CAN-NCIC-BR24
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Secondary ID [2]
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BR24
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - carboplatin
Treatment: Drugs - cediranib maleate
Treatment: Drugs - paclitaxel
Other interventions - placebo
Experimental: Arm I - Patients receive oral cediranib maleate once daily in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment with paclitaxel and carboplatin repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Active Comparator: Arm II - Patients receive oral placebo once daily in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel and carboplatin as in arm I.
Treatment: Drugs: carboplatin
Given IV
Treatment: Drugs: cediranib maleate
Given orally
Treatment: Drugs: paclitaxel
Given IV
Other interventions: placebo
Given orally
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Toxicity
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Quality of Life
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Assessment method [2]
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Overall survival
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Assessment method [3]
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Correlative Studies
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Assessment method [4]
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Timepoint [4]
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3 years
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting
1 of the following stage criteria:
- Stage IIIB disease
- Patients without pleural effusion who are not candidates for combined
modality treatment OR who were treated at centers where combined modality
treatment is not considered standard treatment are eligible
- Stage IV disease
- Measurable disease (phase II)
- Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm by
x-ray, ultrasound, physical exam, or conventional CT scan OR = 10 mm by spiral CT
scan
- Measurable lesions must be outside a previous radiotherapy field if they are the
sole site of disease, unless disease progression has been documented
- No significant central thoracic lesion with any appreciable cavitation
- Measurable or nonmeasurable disease (phase III)
- No necrotic or hemorrhagic tumor or metastases
- No untreated brain or meningeal metastases
- CT scans are not required to rule out disease unless there is clinical suspicion
of CNS disease
- Patients with previously treated stable brain metastases (by radiography or
clinical exam) are eligible provided they are asymptomatic and do not require
corticosteroids
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count = 1,500/mm^3
- Platelet count = 100,000/mm^3
- No overt bleeding (i.e., = 30 mL/episode) within the past 3 months
Hepatic
- Bilirubin = 1.5 times upper limit of normal (ULN)
- ALT = 2 times ULN (< 5 times ULN if liver metastases are present)
Renal
- Creatinine clearance = 50 mL/min
- Proteinuria = grade 1
Cardiovascular
- Mean QTc = 470 msec (with Bazett's correction) by ECG
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past year
- No cardiac ventricular arrhythmias requiring medication
- No history of 2nd- or 3rd-degree atrioventricular conduction defects
- No untreated or uncontrolled cardiovascular condition
- No symptomatic cardiac dysfunction
- No uncontrolled hypertension (i.e., resting blood pressure = 150/100 mm Hg despite
antihypertensive therapy)
- No history of labile hypertension
- No history of poor compliance with antihypertensive medication
- No history of familial long-QT syndrome
Pulmonary
- No clinically relevant hemoptysis (i.e., = 5 mL fresh blood) within the past 4 weeks
- Flecks of blood only in sputum allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective (double method for females; barrier method for
males) contraception
- Able and willing to participate in the quality of life assessment
- No peripheral neuropathy > grade 1
- No prior allergic reaction to drugs containing Cremophor EL®
- No active or uncontrolled infection
- No serious illness or medical condition which would preclude study compliance
- No inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or in situ cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 14 days since prior epidermal growth factor receptor-inhibitor therapy (e.g.,
tyrosine kinase inhibitor, monoclonal antibodies, vaccines, or other agents)
- No prior antiangiogenesis therapy, including any of the following:
- Bevacizumab
- Cediranib maleate
- AZD6474
- PTK787/ZK222584 (PTK/ZK)
- Sunitinib malate
- Concurrent epoetin alfa allowed
Chemotherapy
- At least 12 months since prior adjuvant chemotherapy
- Combined chemotherapy and radiotherapy regimens for locally advanced stage IIIB
disease is not considered adjuvant therapy and is not allowed
- No prior chemotherapy for metastatic or recurrent NSCLC
Endocrine therapy
- See Disease Characteristics
- At least 1 week since prior steroids
Radiotherapy
- See Disease Characteristics
- At least 21 days since prior radiotherapy except for low-dose non-myelosuppressive
radiotherapy with approval
- Concurrent palliative radiotherapy allowed with approval
Surgery
- At least 14 days since prior major surgery
Other
- Recovered from prior therapy
- Prior treatment with cyclooxygenase-2 inhibitors allowed
- Concurrent prophylactic anticoagulation (e.g., warfarin) allowed provided requirements
for INR are met
- No potent inhibitors of CYP3A4 and 2C8, including any of the following drugs:
- Amiodarone hydrochloride
- Clarithromycin
- Citalopram hydrobromide
- Erythromycin
- Omeprazole
- Simvastatin
- Atorvastatin
- Lovastatin
- Montelukast sodium
- Verapamil hydrochloride
- Ketoconazole
- Miconazole
- Indinovir and other antivrails
- Diltiazem
- No other concurrent experimental drug or anticancer therapy
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2013
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Sample size
Target
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Accrual to date
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Final
296
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Brazil
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State/province [2]
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Rio de Janeiro
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Country [3]
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Canada
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State/province [3]
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Alberta
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Country [4]
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Canada
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State/province [4]
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British Columbia
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Canada
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State/province [6]
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Quebec
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Country [7]
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Romania
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State/province [7]
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Bucharest
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Country [8]
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Romania
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State/province [8]
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Cluj-Napoca
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Country [9]
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Romania
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State/province [9]
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Sibiu
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Country [10]
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Singapore
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State/province [10]
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
NCIC Clinical Trials Group
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Cediranib maleate 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. Giving paclitaxel and
carboplatin together with AZD2171 may kill more tumor cells. It is not yet known whether
giving paclitaxel and carboplatin together with AZD2171 is more effective than giving
paclitaxel and carboplatin together with a placebo in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving paclitaxel and
carboplatin together with cediranib maleate works and compares it to giving paclitaxel and
carboplatin together with placebo in treating patients with stage III or stage IV non-small
cell lung cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00245154
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Trial related presentations / publications
Bradbury PA, Twumasi-Ankrah P, Ding K, et al.: The impact of brain metastases on overall survival (OS) in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) clinical trials (CT) in advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-8075, 2009.
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Public notes
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Contacts
Principal investigator
Name
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Glenwood D. Goss, MD, BCh, FCP, FRCPC
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Address
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Ottawa Regional Cancer Centre
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00245154
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