None listed
Conditions
Brief summary
This study looks at treatment with the drug Cediranib, in patients who have advanced or metastatic lung cancer. Who is it for? You can join this study if you have advanced or metastatic non-small cell lung cancer. Trial details: Participants will be randomly divided into two groups. Both groups will receive intraveneous chemotherapy treatment. The first group will also receive the new drug Cediranib. The second group will receive a dummy (placebo) treatment. Both groups will receive the chemotherapy drugs Paclitaxel and Carboplatin. This will be administered intraveneously once every 3weeks. The number of cycles will be determined by the physician. No more than 6 cycles will be administered. The group receiving the drug Cediranib will receive a daily dose of 20mg, administered orally, in addition to the chemotherapy treatment. The group receiving the dummy treatment will receive a daily dose, administered orally, in addition to the chemotherapy treatment. The study aims to see whether combining the drug Cediranib with chemotherapy treatment, compared with chemotherapy alone, improves overall survival rates. The study also looks at quality of life.
Interventions
All subjects randomised to receive cediranib will receive paclitaxel(200mg/m2)/carboplatin Area Under the Curve 6 (AUC6) treatment intraveneously, once every 3 weeks, in combination with daily cediranib (20mg delivered orally) for a maximum of 6 cycles (Each cycle should last 21 days. There are no breaks between cycles). The number of cycles administered will be determined by the treating physician. Following this, cediranib will continue to be administered daily until unmanageable toxicity o
All subjects randomised to receive cediranib will receive paclitaxel(200mg/m2)/carboplatin Area Under the Curve 6 (AUC6) treatment intraveneously, once every 3 weeks, in combination with daily cediranib (20mg delivered orally) for a maximum of 6 cycles (Each cycle should last 21 days. There are no breaks between cycles). The number of cycles administered will be determined by the treating physician. Following this, cediranib will continue to be administered daily until unmanageable toxicity or disease progression.
Sponsors
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Histologically or cytologically confirmed non-small cell carcinoma of the lung. -Stage IIIB or IV disease - Measurable disease, defined as at least 1 measurable lesion – tumour lesion: = 20 mm by chest x-ray, physical exam or = 10 mm by spiral Computerised Tomography (CT) scan; = 15mm for nodes (in the first 260 patients randomized). NOTE: Measurable or non-measurable disease allowed after the first 260 patients. -Adequate haematological, renal and hepatic function as defined in the protocol - Eastern Cooperative Oncology Group (ECOG) performance status 0-1. - Must be fit for combined modality treatment. - Sufficiently fluent and willing to complete quality-of-life questionnaires. - Recovered from all prior therapy - No prior chemotherapy for metastatic or recurrent disease (Prior cox-2 inhibitors in standard doses allowed) - At least 12 months since prior adjuvant chemotherapy for completely resected disease(Combined chemotherapy/radiotherapy regimens for locally advanced stage IIIB disease not allowed)
Exclusion criteria
- Untreated brain or meningeal metastases (Patients with treated and radiologic or clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided the metastases are asymptomatic and do not require corticosteroids) - Appreciable cavitation in central thoracic lesions - Other malignancy within the past 5 years, except in situ cancer, basal cell or squamous cell skin cancer, or malignancy cured by definitive prior therapy alone (e.g., surgery) and continuously disease-free for at least 5 years - Mean QTc with Bazett correction > 470 msec in screening Electrocardiogram (ECG) - History of familial long QT syndrome - Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction including any of the following: Unstable angina, congestive heart failure, myocardial infarction within the past year, cardiac ventricular arrhythmias requiring medication, history of second or third degree atrioventricular conduction defects - Left Ventricular Ejection Fraction (LVEF) > 50% in patients with significant cardiac history, even if controlled - Resting Blood Pressure (BP) consistently > 150 mm Hg systolic and/or > 100 mm Hg diastolic - Poorly controlled hypertension - History of labile hypertension or poor compliance with anti-hypertensive medication - Overt bleeding (> 30 mL bleeding/episode) from any site within the past 3 months - Clinically relevant hemoptysis (> 5 mL fresh blood) within the past 4 weeks (Flecks of blood in sputum allowed) - Active or uncontrolled infections, or serious illnesses or medical conditions which would not permit the patient to be treated according to the study - Prior allergic reactions to drugs containing Cremophor EL (R). - Inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis) - Documented weight loss > 10% within the past 3 months (Patients with weight loss 5-10% or whose weight loss status is unknown are eligible provided serum albumin levels are = 30 g/L) - Peripheral neuropathy > grade 1 - Pregnant or nursing - Prior anti-angiogenic therapy - At least 21 days since prior radiotherapy
Outcome results
None listed