Kidney CancerPhase 2NCT00626509
Sunitinib Before or After Surgery in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing sunitinib malate, adjuvant therapy and neoadjuvant therapy in people with Kidney Cancer, run by Gruppo Italiano Carcinoma Renale at 1 site in Italy.
Trial summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- sunitinib malate, adjuvant therapy and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Jan 2011
- 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
DISEASE CHARACTERISTICS:
- Proven metastatic renal cell carcinoma
- Measurable disease (according to RECIST criteria)
- Eligible for cytoreductive nephrectomy
- Primary tumor is considered amenable to surgical extirpation by the attending surgeon
- Thrombosis of the inferior vena cava below the epathic veins allowed
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Adequate hematology and coagulation
- Amylase and lipase normal
- Adequate hepatic, renal, and cardiac function
- Not pregnant
- Negative pregnancy test
- No uncontrolled hypertension and/or clinically significant cardiovascular events or disease within the past 12 months
- No other cancer within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior early nephrectomy due to clinical condition
- No prior systemic therapy for renal cell carcinoma (e.g., chemotherapy, hormonal therapy, interferon, interleukin-2, lymphocyte-activated killer cells, or other biological response modifiers)
- More than 12 days since prior potent CYP3A4 inducers, including any of the following:
- Rifampin
- Rifabutin
- Carbamazepine
- Phenobarbital
- Phenytoin
- St. John's wort
- Efavirenz
- Tipranavir
- More than 7 days since prior potent CYP3A4 inhibitors, including any of the following:
- Ketoconazole
- Itraconazole
- Clarithromycin
- Erythromycin
- Diltiazem
- Verapamil
- Delavirdine
- Indinavir
- Saquinavir
- Ritonavir
- Atazanavir
- Nelfinavir
- No other concurrent approved or investigational anticancer treatment, including chemotherapy, biological response modifiers, hormonal therapy, or immunotherapy
- No concurrent participation in any other treatment clinical trial
- No concurrent palliative radiotherapy or surgery
- No concurrent drugs with proarrhythmic potential, including any of the following:
- Terfenadine
- Quinidine
- Procainamide
- Disopyramide
- Sotalol
- Probucol
- Bepridil
- Haloperidol
- Risperidone
- Indapamide
- Flecainide
- Concurrent bisphosphonate therapy for metastatic bone disease allowed provided therapy was initiated at least 4 weeks prior to the first dose of study drug
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Sacro Cuore
Negrar, 37024
Contact Person, 39-045-601-3912
About this study
Official title: Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the activity of sunitinib malate when administered before vs after cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal cell carcinoma.
- To compare the safety of these regimens in these patients.
Secondary
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment beyond 1 year at the discretion of the investigator.
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
- Conditions
- Kidney Cancer
- Being tested
- sunitinib malate, adjuvant therapy, neoadjuvant therapy, therapeutic conventional surgery
- Keywords
- stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
adjuvant therapyProcedure or surgery
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Adverse events as assessed by NCI CTCAE v3.0
Secondary outcomes (3)
Time to progression
Duration of response
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Randomised
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Carcinoma Renale
- Sponsor type
- University, hospital or other
- Investigators
- Marco Venturini, MD, Principal investigator, Ospedale Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626509
- Sponsor's protocol ID
- GICR-GIR-1
- Other IDs
- CDR0000588423, EUDRACT-2007-005977-67
- Status last verified
- Jun 2009
- First submitted
- 28 Feb 2008
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00626509
- Acronym / sponsor ID
- GICR-GIR-1
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gruppo Italiano Carcinoma RenaleUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2011 (estimated)
- First posted
- 29 Feb 2008 (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.
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective when given before or after surgery in treating kidney cancer.
PURPOSE: This randomized phase II trial is studying the side effects of sunitinib and to compare how well it works when given before or after surgery in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the activity of sunitinib malate when administered before vs after cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal cell carcinoma.
- To compare the safety of these regimens in these patients.
Secondary
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment beyond 1 year at the discretion of the investigator.
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sunitinib malate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Adverse events as assessed by NCI CTCAE v3.0
3 secondary outcomes
Time to progression
Duration of response
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Marco Venturini, MD principal investigator
Ospedale Sacro Cuore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib malate, adjuvant therapy and neoadjuvant therapy in people with Kidney Cancer, run by Gruppo Italiano Carcinoma Renale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria. The study lists 2 primary outcomes in all. 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 12 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.