Clinical trial NCT00245154 (phase 2/phase 3, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, cediranib maleate, paclitaxel
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Eligibility 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