Genitourinary CancerPhase 2NCT02060370
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
A Phase 2 study testing Sunitinib and Questionnaire in people with Genitourinary Cancer and Kidney Cancer, run by M.D. Anderson Cancer Center at 5 sites in United States.
Trial summary
The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genitourinary Cancer, Kidney Cancer
- What is being tested?
- Sunitinib and Questionnaire
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2014to 2 Jan 2019
- 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-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
- Age >/=18 years
- Measurable or evaluable metastatic disease per RECIST v 1
- ECOG performance status 0-1
- Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) </= 2.5 x laboratory upper limit of normal (ULN); Total serum bilirubin </= 2.0 x ULN; Absolute neutrophil count (ANC) >/= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium </= 12.0 mg/dL; Serum creatinine </= 2.5 mg/dL
- Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
- Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)
- Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Current treatment on another therapeutic clinical trial
Show all 10Show fewer
- Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding
- Pregnant or breastfeeding women are excluded from this study because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib. Breastfeeding must be discontinued if the mother is treated with sunitinib
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Lineberger Cancer Center
Chapel Hill, North Carolina, 27514
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which you do not receive any study drug. This will then be repeated every 3 weeks.
Every 6 weeks will be 1 study cycle.
If you have any side effects tell the study doctor right away. The study doctor may change your dose of the study drug.
Study Visits:
Every day during the first week, and then at least 1 time each week during the study, your blood pressure will be checked (either at home, at the clinic, or by your local doctor). You will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
- You will fill out a questionnaire about the quality of your life and about how you are feeling. This should take about 5 minutes.
On Day 42 of every cycle:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
On Day 42 of every even-numbered cycle (Cycles 2, 4, 6, and so on):
- You will have a CT scan of your chest, abdomen, and pelvis.
- Blood (about 1 tablespoon) will be drawn to check your thyroid function.
- Blood (about 2 tablespoons) will be drawn for biomarker testing. (Cycles 2 , 4, and 6 only)
- You will fill out the questionnaire about the quality of your life and about how you are feeling. (Cycles 2 , 4, and 6 only)
At any time that the doctor thinks it is needed, additional blood (about 1 tablespoon) may be drawn to check your thyroid function, and you may need to have a bone scan and CT scan or MRI of the brain to check the status of the disease.
Length of Study:
You may continue taking the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off treatment if the disease gets worse, intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the follow-up visit. However, the study team may perform a medical record review or follow-up call to check on how you are doing. If you are called, this should last about 5-10 minutes.
End-of-Treatment Visit:
After you are no longer receiving the study drug, you will have an end-of-treatment visit. You will have a physical exam and blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
End-of- Treatment Follow-Up Visit:
About 30 days after your end-of-treatment visit you will have a follow-up visit and the following procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
- You will have CT scans of your chest, abdomen and pelvis to check the status of the disease.
This is an investigational study. Sunitinib is FDA approved and commercially available to treat advanced kidney cancer. The dosing schedule being used on this study is investigational.
Up to 60 participants will be enrolled in this study. Up to 60 may take part at MD Anderson.
- Conditions
- Genitourinary Cancer, Kidney Cancer
- Being tested
- Sunitinib, Questionnaire
- Keywords
- Genitourinary Cancer, Kidney Cancer, Metastatic Renal Cell Carcinoma, mRCC, Sunitinib, Sunitinib malate, SUO11248, Sutent, Questionnaire, Survey
- Medical subject headings
- Urogenital Neoplasms, Kidney Neoplasms, 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 Sunitinib Malate, SUO11248, Sutent
Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks. Receives: Drug: Sunitinib; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Toxicity
Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Progression is defined 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
Measured: 17 months
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.
Measured: 2 years
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.
Measured: 36 weeks from the start of treatment
Changes in Circulating DNA Levels With Antiangiogenic Treatment
Measured: Not applicable due data not generated due to timing and budgetary issues
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startAug 2014
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genitourinary CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Eric Jonasch, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060370
- Sponsor's protocol ID
- 2013-0944
- Other IDs
- NCI-2014-01908
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2014
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jonasch E, Slack RS, Geynisman DM, Hasanov E, Milowsky MI, Rathmell WK, Stovall S, Juarez D, Gilchrist TR, Pruitt L, Ornstein MC, Plimack ER, Tannir NM, Rini BI. Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2018 Jun 1;36(16):1588-1593. doi: 10.1200/JCO.2017.77.1485. Epub 2018 Apr 11.
PubMed 29641297
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
- ClinicalTrials.gov ID
- NCT02060370
- Acronym / sponsor ID
- 2013-0944
- Conditions
- Genitourinary Cancer, Kidney Cancer
- Keywords
- Genitourinary Cancer, Kidney Cancer, Metastatic Renal Cell Carcinoma, mRCC, Sunitinib, Sunitinib malate, SUO11248, Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2014 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn more about the safety of giving sunitinib to patients with metastatic kidney cancer for 2 weeks followed by 1 week in which they receive no drug. Researchers want to learn more about the side effects of the drug and the effects of a different dosing schedule.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which you do not receive any study drug. This will then be repeated every 3 weeks.
Every 6 weeks will be 1 study cycle.
If you have any side effects tell the study doctor right away. The study doctor may change your dose of the study drug.
Study Visits:
Every day during the first week, and then at least 1 time each week during the study, your blood pressure will be checked (either at home, at the clinic, or by your local doctor). You will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
- You will fill out a questionnaire about the quality of your life and about how you are feeling. This should take about 5 minutes.
On Day 42 of every cycle:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
On Day 42 of every even-numbered cycle (Cycles 2, 4, 6, and so on):
- You will have a CT scan of your chest, abdomen, and pelvis.
- Blood (about 1 tablespoon) will be drawn to check your thyroid function.
- Blood (about 2 tablespoons) will be drawn for biomarker testing. (Cycles 2 , 4, and 6 only)
- You will fill out the questionnaire about the quality of your life and about how you are feeling. (Cycles 2 , 4, and 6 only)
At any time that the doctor thinks it is needed, additional blood (about 1 tablespoon) may be drawn to check your thyroid function, and you may need to have a bone scan and CT scan or MRI of the brain to check the status of the disease.
Length of Study:
You may continue taking the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off treatment if the disease gets worse, intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the follow-up visit. However, the study team may perform a medical record review or follow-up call to check on how you are doing. If you are called, this should last about 5-10 minutes.
End-of-Treatment Visit:
After you are no longer receiving the study drug, you will have an end-of-treatment visit. You will have a physical exam and blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
End-of- Treatment Follow-Up Visit:
About 30 days after your end-of-treatment visit you will have a follow-up visit and the following procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
- You will have CT scans of your chest, abdomen and pelvis to check the status of the disease.
This is an investigational study. Sunitinib is FDA approved and commercially available to treat advanced kidney cancer. The dosing schedule being used on this study is investigational.
Up to 60 participants will be enrolled in this study. Up to 60 may take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: Sunitinib, Behavioral: QuestionnaireSunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks. |
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 or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
- Age >/=18 years
- Measurable or evaluable metastatic disease per RECIST v 1
- ECOG performance status 0-1
- Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) </= 2.5 x laboratory upper limit of normal (ULN); Total serum bilirubin </= 2.0 x ULN; Absolute neutrophil count (ANC) >/= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium </= 12.0 mg/dL; Serum creatinine </= 2.5 mg/dL
Key exclusion criteria (10 listed)
- Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
- Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)
- Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- New York Heart Association (NYHA) grade II or greater congestive heart failure
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: Sunitinib Malate, SUO11248, SutentStarting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks. | Drug | Sunitinib |
| QuestionnaireAlso: SurveyQuestionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6. | Behavioural | Sunitinib |
Primary outcome
Rate of Toxicity
Time frame: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 17 months
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Time frame: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
Time frame: 2 years
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: 36 weeks from the start of treatment
Changes in Circulating DNA Levels With Antiangiogenic Treatment
Time frame: Not applicable due data not generated due to timing and budgetary issues
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29641297Jonasch E, Slack RS, Geynisman DM, Hasanov E, Milowsky MI, Rathmell WK, Stovall S, Juarez D, Gilchrist TR, Pruitt L, Ornstein MC, Plimack ER, Tannir NM, Rini BI. Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2018 Jun 1;36(16):1588-1593. doi: 10.1200/JCO.2017.77.1485. Epub 2018 Apr 11.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Eric Jonasch, MD principal investigator
M.D. Anderson Cancer Center
5 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 Sunitinib and Questionnaire in people with Genitourinary Cancer and Kidney Cancer, run by M.D. Anderson Cancer Center at 5 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 10 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 27 Feb 2020). 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?
Rate of Toxicity (time frame: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060370, which also lists 1 linked publication.
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 27 Feb 2020.