Anti-inhibitor Coagulant Complex |
Autoplex T; FEIBA VH Immuno |
Clinical Trial: AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) October 2005
Purpose
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
| Intraocular Melanoma Melanoma | Drug: AZD2171 Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Procedure: protein tyrosine kinase inhibitor therapy | Phase II |
MedlinePlus related topics: Eye Cancer; Melanoma
Genetics Home Reference related topics: Eye Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of AZD2171 in Patients With Recurrent or Stage IV Malignant Melanoma
OBJECTIVES:
- Determine the objective tumor response rate in patients with recurrent or stage IV malignant melanoma treated with AZD2171.
- Determine the median survival time, 1-year survival rate, response or stable disease duration, time to disease progression, and clinical benefit response in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate the baseline and post-treatment levels of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcomes in patients treated with this drug.
- Correlate changes in blood flow and vessel permeability, using dynamic contrast-enhanced magnetic resonance imaging pre- and post-treatment, with clinical outcomes in patients treated with this drug.
- Determine the pharmacogenetic analysis of polymorphisms of kdr/flk-1 and other genes in this pathway and correlate genotype with vascular endothelial growth factor levels and response in patients treated with this drug.
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.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant melanoma
- Recurrent or stage IV disease
- The following melanoma types are allowed:
- Acral lentiginous
- Lentigo maligna
- Superficial spreading
- Ocular malignant melanoma
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Previously irradiated lesions are not considered measurable, unless the lesion has subsequently demonstrated progression
- No brain metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- No proteinuria > 1+ by 2 consecutive dipstick urinalyses taken ≥ 1 week apart
Cardiovascular
- QTc < 470 msec
- No uncontrolled hypertension
- Baseline blood pressure must be < 150/100 mm Hg (antihypertensive medication allowed)
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to AZD2171
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 months since prior adjuvant immunotherapy
- No prior immunotherapy for recurrent or metastatic disease
Chemotherapy
- No prior chemotherapy (including regional therapy)
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
Surgery
- More than 4 weeks since prior major surgery
Other
- Recovered from prior therapy
- No prior or concurrent participation in another clinical trial involving biologic agents, chemotherapy, or immunotherapy agents
- The following concurrent medications affecting renal function may be used with caution:
- Vancomycin
- Amphotericin
- Ibuprofen
- Pentamidine
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Location and Contact Information
Ian C. Quirt, MD, Study Chair, Princess Margaret Hospital
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: December 8, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00243061
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Anti-inhibitor Coagulant Complex (Drug Digest)
- Autoplex T (Drug Digest)

Not Signed In -

