Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

NCT02060370 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0944NCI-2014-01908
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Genitourinary Cancer; Kidney Cancer

Keywords

Genitourinary Cancer; Kidney Cancer; Metastatic Renal Cell Carcinoma; mRCC; Sunitinib; Sunitinib malate; SUO11248; Sutent; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  17 months

• The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event

  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

  2 years

• Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)

  36 weeks from the start of treatment

• Changes in Circulating DNA Levels With Antiangiogenic Treatment

  Not applicable due data not generated due to timing and budgetary issues

Study Arms (1)

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.

Drug: Sunitinib; Behavioral: Questionnaire

Interventions

Sunitinib DRUG

Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Also known as: Sunitinib Malate, SUO11248, Sutent

Sunitinib

Questionnaire BEHAVIORAL

Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Also known as: Survey

Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (5)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Lineberger Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 29641297 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Urogenital Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
• Organization: University of Texas MD Anderson Cancer Center

ejonasch@mdanderson.org

713-792-2830

Study Officials

• Eric Jonasch, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: August 1, 2014
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Locations

US (5)