Renal Cell CarcinomaPhase 2NCT00556205
Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma
A Phase 2 study testing Sunitinib and Bevacizumab in people with Renal Cell Carcinoma, run by Massachusetts General Hospital.
Trial summary
The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Sunitinib and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 confirmed metastatic renal cell carcinoma with clear cell histology
- Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
- Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
- Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
- Participants must have received at least 14 doses of sunitinib therapy
- Participants must enroll within 3 months of the last dose of sunitinib
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- Males or females, age of 18 years or older
- ECOG Performance status 0-2
- Resolution of all acute toxic effects of prior therapy, radiotherapy or surgical procedures to NCI CTCAE version 3.0 grade 1 or less
- Laboratory values as defined in protocol
- 4 weeks or more must have elapsed from the time of major surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- No anticipated need for major surgical procedure during the course of the study
- 2 weeks or more must have elapsed from the time of minor surgery and subjects must have recovered from the procedure prior to day 1 of randomization
- 4 weeks of more must have elapsed from the time of major radiotherapy prior to day 1 of randomization
Who cannot join
- Prior treatment with bevacizumab
- Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
- Prior systemic therapy for RCC with > 2 regimens
- Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
- Uncontrolled high blood pressure
- Any prior history of hypertensive crisis or hypertensive encephalopathy
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- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 3 months prior to day 0
- Any of the following within the 6 months prior to sudy drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, symptomatic congestive heart failure, or ejection fraction < 30%
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range without medication
- History of or known brain metastases or spinal cord compression
- NCI CTCAE grade 2 or above hemorrhage within 4 weeks of starting study treatment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Grade 3 or higher cardiac dysrhythmia or QT prolongation
- Concurrent use of proarrhythmic medications including terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide
- Pregnancy or breastfeeding or inadequate contraception
- Significant thromboembolic event within 6 months
- Evidence of bleeding diathesis or coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Proteinuria at screening
- Known hypersensitivity to any component of bevacizumab
- Psychiatric illness/social situation that would limit compliance with study requirements
- Previous or concurrent malignancy requiring active systemic therapy
About this study
Official title: Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma
The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.
Read the detailed description
- Participants will receive one of two treatment possibilities. Since no one knows which of the study options is best, participants will be "randomized" to one fo the three treatment groups.
- Group 1 will stop their current treatment with sunitinib and receive a dose of bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of sunitinib with the addition of bevacizumab.
- All study participants will undergo the same study procedures. These study procedures will include the following at intervals specified in the protocol: medical history review; vital signs; physical exam; urine analysis; EKG and CT scan.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Sunitinib, Bevacizumab
- Keywords
- mRCC, sunitinib, bevacizumab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called sutent
Sunitinib orally once daily
BevacizumabDrug
Also called avastin
Intravenously every 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bevacizumab monotherapy 10 mg/kg IV q2 weeks Receives: Drug: Bevacizumab |
| 2 | Active comparator | Combination Sunitinib \& Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule Receives: Drug: Sunitinib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.
Measured: Until tumor progression
Secondary outcomes (3)
To determine the overall response rate in this patient population.
Measured: Until tumor progression
To evaluate the safety and tolerability of these treatments in mRCC patients with disease progression on standard dose sunitinib.
Measured: Until tumor progression
To collect serum research samples for analysis of predictive biomarkers of response.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startSep 2009
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Toxicity of combination from other trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Pfizer
- Responsible party
- Principal investigator, Dror Michaelson, MD, Massachusetts General Hospital
- Investigators
- M. Dror Michaelson, MD, PhD, Principal investigator, Massachusetts General Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556205
- Sponsor's protocol ID
- 07-202
- Status last verified
- Mar 2016
- First submitted
- 7 Nov 2007
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data to share
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00556205
- Acronym / sponsor ID
- 07-202
- Conditions
- Renal Cell Carcinoma
- Keywords
- mRCC, sunitinib, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Toxicity of combination from other trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Pfizer
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.
Detailed description
- Participants will receive one of two treatment possibilities. Since no one knows which of the study options is best, participants will be "randomized" to one fo the three treatment groups.
- Group 1 will stop their current treatment with sunitinib and receive a dose of bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of sunitinib with the addition of bevacizumab.
- All study participants will undergo the same study procedures. These study procedures will include the following at intervals specified in the protocol: medical history review; vital signs; physical exam; urine analysis; EKG and CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BevacizumabBevacizumab monotherapy 10 mg/kg IV q2 weeks |
| 2 | Active comparator | Drug: Sunitinib, Drug: BevacizumabCombination Sunitinib \& Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed metastatic renal cell carcinoma with clear cell histology
- Patients must be off sunitinib for 14 days prior to day 1 of treatment on protocol
- Evidence of unidimensionally measurable disease based on RECIST criteria, with at least 1 measurable lesion
- Radiographic evidence of disease progression defined by RECIST during or within 6 weeks of completion of sunitinib treatment
- Participants must have received at least 14 doses of sunitinib therapy
Key exclusion criteria (23 listed)
- Prior treatment with bevacizumab
- Unacceptable toxicity on prior sunitinib therapy at 37.5mg or lower
- Prior systemic therapy for RCC with > 2 regimens
- Systemic therapy other than sunitinib within 4 weeks of starting the study treatment
- Uncontrolled high blood pressure
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 |
|---|---|---|
| SunitinibAlso: sutentSunitinib orally once daily | Drug | 2 |
| BevacizumabAlso: avastinIntravenously every 14 days | Drug | 1, 2 |
Primary outcome
To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab.
Time frame: Until tumor progression
3 secondary outcomes
To determine the overall response rate in this patient population.
Time frame: Until tumor progression
To evaluate the safety and tolerability of these treatments in mRCC patients with disease progression on standard dose sunitinib.
Time frame: Until tumor progression
To collect serum research samples for analysis of predictive biomarkers of response.
Time frame: Two months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No. No data to share
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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.
M. Dror Michaelson, MD, PhD principal investigator
Massachusetts General Hosptial
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib and Bevacizumab in people with Renal Cell Carcinoma, run by Massachusetts General Hospital.
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 14 inclusion and 23 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: withdrawn, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab. (time frame: Until tumor progression). 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 24 Mar 2016.