Status:
COMPLETED
Cediranib, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways t...
Detailed Description
OBJECTIVES: Primary * To compare overall survival of patients with stage IIIB-IV non-small cell lung cancer treated with cediranib vs placebo administered in combination with paclitaxel and carbopla...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically\* confirmed non-small cell carcinoma of the lung
- Stage IIIB or IV disease NOTE: \*Diagnosis by sputum cytology alone allowed provided it is confirmed by a second sputum specimen
- Measurable disease, defined as at least 1 measurable lesion \> 20 mm by x-ray, ultrasound, or physical exam or ≥ 10 mm (lymph nodes must be ≥ 15 mm in the short axis) by spiral CT scan or physical exam (in the first 260 patients randomized\*\*)
- Measurable lesions that are sole sites of disease must be outside a previous radiotherapy field unless disease progression has been documented NOTE: \*\*Measurable or nonmeasurable disease allowed after the first 260 patients
- No appreciable cavitation in central thoracic lesions
- No 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
- No pleural effusion
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine clearance \> 50 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 2 times ULN (\< 5 times ULN if due to liver metastasis)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception (barrier method for men)
- No 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 ≤ 480 msec in screening ECG (at least one value must be ≤ 480 msec when measured automatically or manually corrected using Bazett's or Fridericia's correction)
- No history of familial long QT syndrome
- No 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
- LVEF \> 50% in patients with significant cardiac history, even if controlled
- No resting BP consistently \> 150 mm Hg systolic and/or \> 100 mm Hg diastolic
- No poorly controlled hypertension
- No history of labile hypertension or poor compliance with anti-hypertensive medication
- No overt bleeding (\> 30 mL bleeding/episode) from any site within the past 3 months
- No clinically relevant hemoptysis (\> 5 mL fresh blood) within the past 4 weeks
- Flecks of blood in sputum allowed
- No active or uncontrolled infections, or serious illnesses or medical conditions which would not permit the patient to be treated according to the study
- No prior allergic reactions to drugs containing Cremophor EL®
- No inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis)
- No 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
- No peripheral neuropathy \> grade 1
- Must be fit for combined modality treatment
- Sufficiently fluent and willing to complete quality-of-life questionnaires
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior chemotherapy for metastatic or recurrent disease
- No prior anti-angiogenic therapy (e.g., bevacizumab, cediranib, AZD6474, PTK/ZK, sunitinib malate, or other agents considered angiogenesis inhibitors by NCIC Clinical Trials Group for any indication)
- 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
- At least 21 days since prior radiotherapy
- At least 21 days since prior cetuximab or other monoclonal antibodies
- At least 14 days since prior EGFR inhibitor therapy for adjuvant therapy or metastatic disease (e.g., tyrosine kinase inhibitors, vaccines, or other agents considered by NCIC CTG as acting on the EGFR pathway)
- At least 14 days since prior major surgery
- At least 1 week since prior corticosteroids
- No other concurrent experimental drugs, anticancer treatment, or investigational therapy
Exclusion
Key Trial Info
Start Date :
February 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2014
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00795340
Start Date
February 4 2009
End Date
January 16 2014
Last Update
August 22 2023
Active Locations (19)
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1
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, Brazil, CEP20231-050
2
Instituto de Cancer Arnaldo Vieira de Carvalho
São Paulo, Brazil, 01224-010
3
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
4
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2