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A Phase 2 Study of AZD2171 in Progressive Unresectable, Recurrent or Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

A Phase 2 Study of AZD2171 in Progressive Unresectable, 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.

Inclusion Criteria


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

- No New York Heart Association class III or IV disease

- Class II disease with increased monitoring is allowed

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

- No drugs or biologics with proarrythmic potential

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate and rate of stable disease ≥ 4 months

Safety Issue:

No

Principal Investigator

Srikala Sridhar, MD, FRCPC, MSC

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

CDR0000446080

NCT ID:

NCT00227760

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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