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About
This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Full description
PRIMARY OBJECTIVES:
I. To assess the objective tumor response rate of AZD2171 administered to patients with recurrent or metastatic malignant melanoma.
II. To assess the toxicity, median survival time, 1-year survival rate, response or stable disease duration, time to disease progression and clinical benefit response of AZD2171 administered to patients with recurrent or metastatic malignant melanoma.
III. To measure baseline and post-treatment levels of angiogenic growth factors and receptors, as well as circulating endothelial cells, and to explore the relationship between these potential correlative endpoints and clinical outcome.
IV. To assess changes in blood flow and vessel permeability using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) pre- and post-treatment, and to explore the relationship between these potential imaging endpoints and clinical outcome.
V. To look for polymorphisms of kdr/flk-1, and other genes in this pathway, by performing pharmacogenetic analysis of pbmc's, and correlate genotype with VEGF levels and response to therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
Enrollment
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Inclusion criteria
Histologically/cytologically confirmed recurrent/metastatic malignant melanoma (stage IV acral lentiginous, lentigo maligna, superficial spreading or ocular malignant melanoma)
Measurable disease- at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as >=20mm with conventional techniques or >=10mm with spiral CT scan
No prior chemotherapy (including regional therapy); prior adjuvant immunotherapy permitted if completed >3 months prior to study entry; patients may have received prior radiation therapy if completed >=4 weeks prior to study entry
Life expectancy >12 weeks
ECOG performance status=< 2 (Karnofsky>=60%)
Leukocytes>=3,000/mcL
Absolute neutrophil count>=1,500/mcL
Platelets>=100,000/mcL
Hemoglobin>=8g/dL
Total bilirubin<1.5x institutional ULN (IULN)
AST/ALT=<3 x IULN (5xULN if liver metastases)
Creatinine within IULN
Creatinine within IULN OR
Creatinine clearance>=60mL/min/m^2 if creatinine levels above IULN
Baseline blood pressure <140/90mmHg; may be taking antihypertensive medications
AZD2171 has shown to terminate fetal development in rat as expected for process dependent on VEGF signaling; women of childbearing potential must have negative pregnancy test prior to study entry; women of childbearing potential/men must agree to use adequate contraception (hormonal/barrier method of birth control; abstinence) prior to study entry and for duration of study
Ability to understand/willingness to sign written informed consent
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Primary purpose
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24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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