Renal CancerPhase 2NCT00455975
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
A Phase 2 study testing Bevacizumab in people with Renal Cancer and Kidney Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.
Trial summary
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Kidney Cancer
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2007to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- No prior bevacizumab
- Measurable disease
- Adequate liver and kidney function
- Age 18 and older
Who cannot join
- Acute MI within the past 6 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Clinically significant cardiovascular disease
- Active brain cancer
- Meningeal metastasis
- Pregnant or lactating women
Show all 16Show fewer
- Prior treatment for another cancer less than 5 years ago
- No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
- No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
- No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
- No major surgical procedures, open biopsies or traumatic injury in past 28 days
- No patients with peg tubes or feeding tubes
- No patients with non healing wounds, ulcers or long bone fractures
- No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
- No symptomatic peripheral vascular disease
- Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Family Cancer Center
Collierville, Tennessee, 38017
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Peninsula Cancer Institute
Newport News, Virginia, 23601
Methodist Cancer Center
Omaha, Nebraska, 68114
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
Read the detailed description
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.
One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.
If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
- Conditions
- Renal Cancer, Kidney Cancer
- Being tested
- Bevacizumab
- Keywords
- Kidney Cancer, Renal Cancer, Clear Cell Carcinoma
- Medical subject headings
- Kidney Neoplasms, Adenocarcinoma, Clear Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Weekly Avastin | Experimental | Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity Receives: Drug: Bevacizumab |
| Bi-weekly Avastin | Experimental | Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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
Measured: 18 months (expected)
Secondary outcomes (3)
Overall Survival (OS)
Measured from date of study entry to date of death due to any cause.
Measured: 18 months
Objective Response Rate
The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Measured: 18 months
Overall Tolerability and Toxicity of High-dose Bevacizumab
Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John D. Hainsworth, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455975
- Sponsor's protocol ID
- SCRI GU 43
- Other IDs
- AVF 3913s
- Status last verified
- Dec 2014
- First submitted
- 3 Apr 2007
- Last updated
- 22 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
- ClinicalTrials.gov ID
- NCT00455975
- Acronym / sponsor ID
- SCRI GU 43
- Conditions
- Renal Cancer, Kidney Cancer
- Keywords
- Kidney Cancer, Renal Cancer, Clear Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
Detailed description
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.
One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.
If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Avastin | Experimental | Drug: BevacizumabBevacizumab 15mg/kg IV weekly until progressive disease or toxicity |
| Bi-weekly Avastin | Experimental | Drug: BevacizumabBevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- No prior bevacizumab
- Measurable disease
Key exclusion criteria (16 listed)
- Acute MI within the past 6 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Clinically significant cardiovascular disease
- Active brain cancer
- Meningeal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab | Drug | Bi-weekly Avastin, Weekly Avastin |
Primary outcome
Progression-free Survival
Time frame: 18 months (expected)
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 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
3 secondary outcomes
Overall Survival (OS)
Time frame: 18 months
Objective Response Rate
Time frame: 18 months
Overall Tolerability and Toxicity of High-dose Bevacizumab
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Hainsworth, M.D. study chair
SCRI Development Innovations, LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Renal Cancer and Kidney Cancer, run by SCRI Development Innovations, LLC at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 18 months (expected)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2014.