ZD6474 in Treating Patients With Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, limited stage small cell lung cancer
Eligibility 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
Sites / Locations
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute at University of Alberta
- British Columbia Cancer Agency - Centre for the Southern Interior
- Fraser/Valley Cancer Centre at British Columbia Cancer Agency
- British Columbia Cancer Agency - Vancouver Cancer Centre
- Moncton Hospital
- Saint John Regional Hospital
- Margaret and Charles Juravinski Cancer Centre
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Ottawa Hospital Regional Cancer Centre - General Campus
- St. Catharines General Hospital at Niagara Health System
- Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
- Toronto East General Hospital
- Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Windsor Regional Cancer Centre at Windsor Regional Hospital
- Hopital Notre- Dame du CHUM
- McGill Cancer Centre at McGill University
- L'Hopital Laval
- Saskatoon Cancer Centre at the University of Saskatchewan