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A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma



- 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.


- To examine, in a preliminary manner, the response rate to bevacizumab in these

- 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.

Inclusion Criteria


- 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 disease


Inclusion criteria:

- ECOG performance status 0-1

- Life expectancy > 6 months

- ANC ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL

- Total bilirubin ≤ 2.0 mg/dL

- AST and ALT < 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate progression free survival (PFS) when Bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

J. Paul Monk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Kidney Cancer
  • papillary renal cell carcinoma
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Ohio State University Medical Center Columbus, Ohio  43210