L-Tyrosine |
Tyrosine |
Clinical Trial: AZD2171 in Treating Patients With Progressive Locally Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 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 AZD2171 to see how well it works in treating patients with progressive locally recurrent or metastatic kidney cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
| Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer | 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: Cancer; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of AZD2171 in Patients With Progressive Unresectable, Locally Recurrent or Metastatic Renal Cell Carcinoma
OBJECTIVES:
- Determine the clinical benefit rate (objective response rate and rate of stable disease for ≥ 4 months) in patients with progressive unresectable, locally recurrent or metastatic renal cell carcinoma treated with AZD2171.
- Determine the duration of response or stable disease in patients treated with this drug.
- Determine progression-free, median, and overall survival of patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
- Correlate levels of soluble markers of angiogenic growth factors and receptors and circulating endothelial cells with clinical outcome in patients treated with this drug.
- Correlate changes in blood flow and vessel permeability with clinical outcome in patients treated with this drug.
OUTLINE: This is a 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 at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell cancer
- Locally recurrent or metastatic disease
- Progressive unresectable disease
- Not considered curable by standard therapy
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Bone lesions are not considered measurable disease
- Sole site of measurable disease may lie within a previously irradiated field provided there has been subsequent documented disease progression
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 60 mL/min
- No proteinuria > +1 on 2 consecutive dipstick tests taken ≥ 1 week apart
Cardiovascular
- QTc ≤ 470 msec (with Bazett''''s correction) by ECG
- No history of familial long QT syndrome
- No hypertension
- 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 study drug
- 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
- No prior immunotherapy or gene therapy
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy, except low-dose, non-myelosuppressive radiotherapy, and recovered
- No concurrent radiotherapy to the sole site of measurable disease
Surgery
- At least 4 weeks since prior major surgery and recovered
Other
- No prior investigational therapy
- No prior participation in another investigational study
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
Location and Contact Information
Srikala Sridhar, MD, Study Chair, Margaret and Charles Juravinski Cancer Centre
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: December 8, 2005
Record first received: September 26, 2005
ClinicalTrials.gov Identifier: NCT00227760
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

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