Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
NCT02060370
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
2. Age >/=18 years
3. Measurable or evaluable metastatic disease per RECIST v 1
4. ECOG performance status 0-1
5. 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
6. Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study.
7. Subjects must have the ability to understand and the willingness to sign a written informed consent document
1. 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)
2. Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with
anti-hypertensives)
3. Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or
radiation therapy within 4 weeks of starting treatment
4. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis
5. New York Heart Association (NYHA) grade II or greater congestive heart failure
6. Current treatment on another therapeutic clinical trial
7. 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
8. 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
9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness
10. 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
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Descriptive Information | |||||
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Brief Title ICMJE | Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC) | ||||
Official Title ICMJE | A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC) | ||||
Brief 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. | ||||
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:
On Day 42 of every cycle:
On Day 42 of every even-numbered cycle (Cycles 2, 4, 6, and so on):
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:
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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Sunitinib
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks. Interventions:
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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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | January 2, 2019 | ||||
Actual Primary Completion Date | January 2, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02060370 | ||||
Other Study ID Numbers ICMJE | 2013-0944 NCI-2014-01908 ( Registry Identifier: NCI CTRP ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |