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Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060370
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Genitourinary Cancer Kidney Cancer Drug: Sunitinib Behavioral: Questionnaire Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
Actual Study Start Date : August 2014
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : January 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Sunitinib
Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Other Names:
  • Sunitinib Malate
  • SUO11248
  • Sutent

Behavioral: Questionnaire
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
Other Name: Survey


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 17 months ]
    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

  2. 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. ]
    Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4

  3. Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities [ Time Frame: 2 years ]
    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.

  4. Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G) [ Time Frame: 36 weeks from the start of treatment ]
    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.

  5. Changes in Circulating DNA Levels With Antiangiogenic Treatment [ Time Frame: Not applicable due data not generated due to timing and budgetary issues ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060370


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, North Carolina
Lineberger Cancer Center
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
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Principal Investigator: Eric Jonasch, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] January 6, 2015

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02060370    
Other Study ID Numbers: 2013-0944
NCI-2014-01908 ( Registry Identifier: NCI CTRP )
First Posted: February 12, 2014    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Genitourinary Cancer
Kidney Cancer
Metastatic Renal Cell Carcinoma
mRCC
Sunitinib
 Sunitinib malate
SUO11248
Sutent
Questionnaire
Survey
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action