Clear Cell Renal Cell CarcinomaPhase 2NCT01158222
Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
A Phase 2 study testing sunitinib malate in people with Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
- What is being tested?
- sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2010to 1 Feb 2017
- 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 or cytologically-proven advanced RCC with a component of clear cell histology
- Measurable disease per RECIST criteria
- ECOG performance status 0-1
- Prior nephrectomy is NOT required
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x laboratory upper limit of normal (ULN)
- Total serum bilirubin ≤ 2.0 x ULN
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- Absolute neutrophil count (ANC) ≥ 1500/uL
- Platelets ≥ 100,000/uL
- Hemoglobin ≥ 8.0 g/dL (transfusion permitted)
- Serum calcium ≤ 12.0 mg/dL
- Serum creatinine ≤ 2.5 mg/dL
- Patients with history of brain metastases can be enrolled at a minimum of 2 weeks following the completion of surgery, gamma knife or whole brain radiotherapy; repeat brain MRI not required for eligibility
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Who cannot join
- Prior systemic treatment for advanced RCC. Prior adjuvant therapy (any drug) is allowed if end of adjuvant therapy was more than 1 year prior to start of sunitinib on this protocol.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism
- Hypertension that cannot be controlled by medications to < 160/90 mmHg
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- Pregnancy or breastfeeding
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
- To determine the clinical outcome (response rate and overall progression-free survival) in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.
II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma.
III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients and investigate the association between the VEGF -634 genotype and the occurrence of hypertension in sunitinib-treated RCC patients.
OUTLINE:
Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule may be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in the absence of unacceptable toxicity or RECIST-defined progressive disease.
- Being tested
- sunitinib malate
- 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.
sunitinib malateDrug
Also called SU011248, SU11248, sunitinib, Sutent
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Measured: after 6 months of treatment (4 cycles)
Secondary outcomes (2)
Change in Circulating Tumor Cells
Measured: Pre-treatment, day 1, and day 28 of every cycle
Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype
Measured: Day 28 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study start18 Aug 2010
- Primary completion20 Jun 2013
- Study completion1 Feb 2017
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 Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Rini, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158222
- Sponsor's protocol ID
- CASE8809
- Other IDs
- NCI-2010-01391
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2010
- Last updated
- 14 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01158222
- Acronym / sponsor ID
- CASE8809
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 18 Aug 2010 (actual)
- Primary completion
- 20 Jun 2013 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 16 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate it works in treating patients with previously untreated metastatic kidney cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
- To determine the clinical outcome (response rate and overall progression-free survival) in metastatic renal cell carcinoma patients treated with intermittent sunitinib therapy.
II. To evaluate the toxicity of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma.
III. To assess the feasibility of detecting circulating tumor cells (CTCs) in RCC patients and investigate the association between the VEGF -634 genotype and the occurrence of hypertension in sunitinib-treated RCC patients.
OUTLINE:
Patients receive oral sunitinib malate once daily on days 1-28. Sunitinib dosing schedule may be changed to 14 days on followed by 7 days off, and repeated for a 6-week cycle, at the discretion of the treating physician for toxicity purposes. Cycles will be defined as 6 week intervals regardless of dosing interruptions. All patients will be treated for 4 cycles in the absence of unacceptable toxicity or RECIST-defined progressive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: sunitinib malatePatients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically-proven advanced RCC with a component of clear cell histology
- Measurable disease per RECIST criteria
- ECOG performance status 0-1
- Prior nephrectomy is NOT required
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x laboratory upper limit of normal (ULN)
Key exclusion criteria (6 listed)
- Prior systemic treatment for advanced RCC. Prior adjuvant therapy (any drug) is allowed if end of adjuvant therapy was more than 1 year prior to start of sunitinib on this protocol.
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass graft, New York Heart Association grade II or greater congestive heart failure, cerebrovascular accident or transient ischemic attack, clinically significant bleeding or pulmonary embolism
- Hypertension that cannot be controlled by medications to < 160/90 mmHg
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- Pregnancy or breastfeeding
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 malateAlso: SU011248, SU11248, sunitinib, SutentGiven orally | Drug | Arm I |
Primary outcome
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
Time frame: after 6 months of treatment (4 cycles)
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
2 secondary outcomes
Change in Circulating Tumor Cells
Time frame: Pre-treatment, day 1, and day 28 of every cycle
Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype
Time frame: Day 28 of each cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- 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.
Brian Rini principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
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 in people with Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer, run by Case Comprehensive Cancer Center at 1 site 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 13 inclusion and 6 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 14 Sep 2018. 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 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 16 Aug 2018). 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?
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it (time frame: after 6 months of treatment (4 cycles)). 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 14 Sep 2018.