Kidney Cancer
Conditions
Keywords
papillary renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer
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.
Interventions
BIOLOGICALbevacizumab
15 mg/kg over 90 minutes every 3 weeks
Sponsors
Genentech, Inc.
Paul Monk
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma. | Up to 2 years | Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Response Rate to Bevacizumab in This Population. | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Bevacizumab in This Population of Patients | Up to 2 years | Grade 3 or higher toxicities according to CTCAE version 3.0 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab 15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma. | 12 months |
Primary
Response Rate to Bevacizumab in This Population.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Time frame: Up to 2 years
Population: Includes patients with Complete response, partial response or stable disease
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab | Response Rate to Bevacizumab in This Population. | Complete Response | 0 patients |
| Bevacizumab | Response Rate to Bevacizumab in This Population. | Progressive Disease | 1 patients |
| Bevacizumab | Response Rate to Bevacizumab in This Population. | Partial Response | 2 patients |
| Bevacizumab | Response Rate to Bevacizumab in This Population. | Stable Disease | 2 patients |
Secondary
Safety of Bevacizumab in This Population of Patients
Grade 3 or higher toxicities according to CTCAE version 3.0
Time frame: Up to 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Safety of Bevacizumab in This Population of Patients | 15 toxicities |