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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00245154




Registration number
NCT00245154
Ethics application status
Date submitted
25/10/2005
Date registered
27/10/2005

Titles & IDs
Public title
Paclitaxel + Carboplatin With/Out Cediranib Maleate in Stage III or Stage IV Non-Small Cell Lung Cancer
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
Secondary ID [1] 0 0
CAN-NCIC-BR24
Secondary ID [2] 0 0
BR24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Toxicity
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Quality of Life
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Correlative Studies
Timepoint [4] 0 0
3 years

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
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2013
Sample size
Target
Accrual to date
Final
296
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio de Janeiro
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Romania
State/province [7] 0 0
Bucharest
Country [8] 0 0
Romania
State/province [8] 0 0
Cluj-Napoca
Country [9] 0 0
Romania
State/province [9] 0 0
Sibiu
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
NCIC Clinical Trials Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glenwood D. Goss, MD, BCh, FCP, FRCPC
Address 0 0
Ottawa Regional Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT00245154