Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Paul Monk

Status and phase

Terminated

Phase 2

Conditions

Kidney Cancer

Treatments

Biological: bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00601926

NCI-2011-03160 (Registry Identifier)

OSU-06111

Details and patient eligibility

About

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.

Full description

OBJECTIVES:

Primary

To evaluate the progression-free survival when bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
To further evaluate the safety of bevacizumab in these patients.

Secondary

To examine, in a preliminary manner, the response rate to bevacizumab in these patients.
To collect and store blood and urine samples for future analysis.
To evaluate overall survival when bevacizumab is administered to these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed papillary renal cell carcinoma (RCC)
- Unresectable and/or metastatic disease
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 10 mm by spiral CT scan
No known CNS (central nervous system) disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG (Eastern Cooperative Oncology Group) performance status 0-1
Life expectancy > 6 months
ANC (absolute neutrophil count) ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL
Total bilirubin ≤ 2.0 mg/dL
AST (aspartate aminotransferase) and ALT (Alanine transaminase) < 3 times normal
Creatinine clearance > 50 mg/mL
Calcium < 12 mg/dL (when corrected for level of serum albumin)
No known HIV infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

Exclusion criteria:

Inadequately controlled hypertension (defined as systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medications)
Prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association class II-IV congestive heart failure
Myocardial infarction or unstable angina within the past 6 months
Stroke or transient ischemic attack within the past 6 months
Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
Symptomatic peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Significant traumatic injury within the past 28 days
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
Serious, non-healing wound, ulcer, or bone fracture
Proteinuria at screening as demonstrated by either of the following:
- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
- Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein > 1g
Known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

No prior systemic treatment for metastatic papillary RCC
At least 4 weeks since prior palliative radiotherapy of painful areas
More than 28 days since prior major surgical procedure or open biopsy
No concurrent major surgical procedure
More than 7 days since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device
Concurrent low-dose acetylsalicylic acid (≤ 325 mg/day) allowed in patients at high-risk for arterial thromboembolic disease