Clinical trial NCT00601926: Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
Official title: A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: papillary renal cell carcinoma
stage III renal cell cancer
stage IV renal cell cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
timeFrame: Up to 2 years
measure: Response Rate to Bevacizumab in This Population.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Safety of Bevacizumab in This Population of Patients
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Paul Monk, MD
role: PRINCIPAL_INVESTIGATOR
References: