This trial is active, not recruiting.

Condition kidney cancer
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Paul Monk
Collaborator Genentech
Start date February 2008
End date December 2013
Trial size 41 participants
Trial identifier NCT00601926, NCI-2011-03160, OSU-06111


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
15 mg/kg over 90 minutes
bevacizumab Avastin
15 mg/kg over 90 minutes every 3 weeks

Primary Outcomes

Evaluate progression free survival (PFS) when Bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
time frame: Up to 2 years
Examine in preliminary manner response rate to Bevacizumab in this population.
time frame: Up to 2 years

Secondary Outcomes

Evaulate safety of Bevacizumab in this population of patients
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 disease PATIENT CHARACTERISTICS: 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 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

Additional Information

Official title A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
Principal investigator J. Paul Monk, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.