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Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bevacizumab

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring papillary renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

15 mg/kg over 90 minutes

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Safety of Bevacizumab in This Population of Patients

Grade 3 or higher toxicities according to CTCAE version 3.0

Full Information

NCT ID

NCT00601926

First Posted

January 22, 2008

Last Updated

May 18, 2015

Sponsor

Paul Monk

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00601926

Brief Title

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

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

Poor patient accrual. Attempts to open at other sites unsuccessful.

Study Start Date

February 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul Monk

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer

Keywords

papillary renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab

Arm Type

Experimental

Arm Description

15 mg/kg over 90 minutes

Intervention Type

Biological

Intervention Name(s)

bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

15 mg/kg over 90 minutes every 3 weeks

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.

Description

Time Frame

Up to 2 years

Title

Response Rate to Bevacizumab in This Population.

Description

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Safety of Bevacizumab in This Population of Patients

Description

Grade 3 or higher toxicities according to CTCAE version 3.0

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Monk, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

Jamesline

Learn more about this trial

Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

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