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 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Clear Cell Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Drug: sunitinib malate
Other: laboratory biomarker analysis
Genetic: reverse transcriptase-polymerase chain reaction
Genetic: polymorphism analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Intermittent Sunitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: August 2010
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158222

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Brian Rini Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01158222     History of Changes
Other Study ID Numbers: CASE8809, NCI-2010-01391
Study First Received: July 6, 2010
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014