ZD6474 in Treating Patients With Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed small cell carcinoma of the lung
• •* Small cell and variant histology allowed
• •* No mixed tumors (small and large cell)
• •* No neuroendocrine tumors of the lung
• •Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen
• •* No prior change in regimen due to disease progression
• •Must have achieved a radiologically confirmed (i.e., CT scan, chest x-ray, or bone scan) complete response (CR) or partial response (PR) after prior chemotherapy with or without radiotherapy AND meets 1 of the following criteria:
• •* No more than 28 days since prior chemotherapy
• •* At least 7 and no more than 14 days since prior radiotherapy if administered after completion of prior chemotherapy\*
• •No CNS metastases
• •* Asymptomatic patients with CNS metastases who received prior therapeutic cranial irradiation and are on stable, decreasing, or no steroids are eligible
• •* No symptomatic lesions or evidence of necrosis or bleeding NOTE: \*Randomization may take place up to 21 days after prior radiotherapy in the instance of severe esophagitis that precludes administration of oral medications
• •PATIENT CHARACTERISTICS:
• •Age
• •Over 16
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 12 weeks
• •Hematopoietic
• •Absolute granulocyte count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •No history of bleeding diathesis
• •Hepatic
• •Bilirubin less than 1.5 times upper limit of normal (ULN)
• •ALT less than 2.5 times ULN
• •Renal
• •Creatinine less than 1.5 times ULN
• •Calcium normal
• •Cardiovascular
• •No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following:
• •* Multifocal premature ventricular contractions
• •* Bigeminy
• •* Trigeminy
• •* Ventricular tachycardia
• •No prior QT prolongation with any medication
• •No congenital long QT syndrome
• •No QT and QTc (with Bazett's correction) that is unmeasurable or is 460 msec or higher on screening ECG
• •No significant cardiac event, including symptomatic heart failure or angina, within the past 3 months or any cardiac disease that increases the risk for ventricular arrhythmia
• •No ongoing chronic atrial fibrillation
• •LVEF at least 45% by MUGA for patients with significant cardiac history (myocardial infarction, severe hypertension, or arrhythmia) OR who received prior doxorubicin greater than 450 mg/m\^2
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Potassium normal
• •Magnesium normal
• •No serious active infection
• •No recent major bleeding
• •No other concurrent serious underlying medical condition that would preclude study participation
• •Willing and able to complete quality of life questionnaires in English or French
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior signal transduction inhibitors
• •No prior angiogenesis inhibitors
• •No concurrent anticancer biologic therapy or immunotherapy
• •Chemotherapy
• •See Disease Characteristics
• •Recovered from prior chemotherapy
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •Recovered from prior radiotherapy
• •No concurrent anticancer radiotherapy
• •* Concurrent low-dose, nonmyelosuppressive palliative radiotherapy allowed
• •Surgery
• •More than 2 weeks since prior major surgery
• •Other
• •More than 4 weeks since prior investigational drugs
• •No prior epidermal growth factor receptor inhibitors
• •No prior vascular endothelial growth factor receptor inhibitors
• •No concurrent CYP3A4 inhibitors or inducers, including any of the following:
• •* Verapamil
• •* Rifampin
• •* Phenytoin
• •* Carbamazepine
• •* Barbiturates
• •* Hypericum perforatum (St. John's wort)
• •No concurrent medication that affects QT/QTc and/or induces torsades de pointes
• •No other concurrent anticancer cytotoxic therapy
• •No other concurrent investigational drugs during and for 30 days after study participation
• •No concurrent oral bisphosphonates (e.g., clodronate)
• •* Concurrent IV bisphosphonates allowed
• •No concurrent 5HT\_3 antagonists