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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

Primary Purpose

Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib malate
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Circulating Tumor Cells
Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype

Full Information

First Posted
July 6, 2010
Last Updated
August 17, 2018
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01158222
Brief Title
Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Official Title
A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 18, 2010 (Actual)
Primary Completion Date
June 20, 2013 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of intermittent sunitinib therapy in patients with metastatic renal cell carcinoma (RCC). SECONDARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
SU011248, SU11248, sunitinib, Sutent
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
Description
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Time Frame
after 6 months of treatment (4 cycles)
Secondary Outcome Measure Information:
Title
Change in Circulating Tumor Cells
Time Frame
Pre-treatment, day 1, and day 28 of every cycle
Title
Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype
Time Frame
Day 28 of each cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Rini
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

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