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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01158222
First received: July 6, 2010
Last updated: October 23, 2014
Last verified: October 2014

July 6, 2010
October 23, 2014
August 2010
October 2015   (final data collection date for primary outcome measure)
Feasibility as assessed by proportion of patients eligible for intermittent therapy who actually receive it [ Time Frame: after 6 months of treatment (4 cycles) ] [ Designated as safety issue: No ]
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Feasibility as assessed by proportion of patients eligible for intermittent therapy who actually receive it [ Time Frame: Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01158222 on ClinicalTrials.gov Archive Site
  • Toxicity as assessed by Common Terminology Criteria for Adverse Events(CTCAE) version 4.0 [ Time Frame: after 6 months of treatment (4 cycles) ] [ Designated as safety issue: Yes ]
  • Change in circulating tumor cells [ Time Frame: Pre-treatment, day 1, and day 28 of every cycle ] [ Designated as safety issue: No ]
  • Relationship between hypertension and germline VEGF single nucleotide polymorphism (SNP) -634 genotype [ Time Frame: Day 28 of each cycle ] [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE version 4.0 [ Time Frame: Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: Yes ]
  • Change in circulating tumor cells [ Time Frame: Pre-treatment, day 1, and day 28 of every cycle ] [ Designated as safety issue: No ]
  • Relationship between hypertension and germline VEGF SNP -634 genotype [ Time Frame: Day 28 of each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer
  • Drug: sunitinib malate
    Given orally
    Other Names:
    • SU011248
    • SU11248
    • sunitinib
    • Sutent
  • Other: laboratory biomarker analysis
    Correlative studies
  • Genetic: reverse transcriptase-polymerase chain reaction
    Correlative studies
    Other Name: RT-PCR
  • Genetic: polymorphism analysis
    Correlative studies
Experimental: Arm I
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.
Interventions:
  • Drug: sunitinib malate
  • Other: laboratory biomarker analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Genetic: polymorphism analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
Not Provided
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01158222
CASE8809, NCI-2010-01391
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
Not Provided
Principal Investigator: Brian Rini Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP