Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood flow to the tumor.
PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo in treating patients with small cell lung cancer that has responded to previous chemotherapy with or without radiation therapy.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, timing of prior radiotherapy (early [before day 1, course 4 of chemotherapy] vs late vs no prior radiotherapy), stage of disease at diagnosis (limited vs extensive), and response at study entry (complete vs partial). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, every 4 weeks while on therapy, and then every 8 weeks until disease progression.
Patients are followed every 8 weeks until disease progression and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell carcinoma of the lung
Must have received at least 4 courses of first-line combination chemotherapy as part of an induction regimen
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 CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No prior ventricular arrhythmia that was symptomatic or required treatment (CTC grade 3), including any of the following:
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
Recovered from prior radiotherapy
No concurrent anticancer radiotherapy
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:
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)
No concurrent 5HT_3 antagonists
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Data sourced from clinicaltrials.gov
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