Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

NCT01158222 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CASE8809NCI-2010-01391
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  after 6 months of treatment (4 cycles)

Secondary Outcomes (2)

• Change in Circulating Tumor Cells

  Pre-treatment, day 1, and day 28 of every cycle

• Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype

  Day 28 of each cycle

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU011248, SU11248, sunitinib, Sutent

Arm I

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-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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Brian Rini
• Organization: Case Comprehensive Cancer Center

rinib2@ccf.org

216-444-9567

Study Officials

• Brian Rini

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive 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: July 6, 2010
• First Posted: July 8, 2010
• Study Start: August 18, 2010
• Primary Completion: June 20, 2013
• Study Completion: February 1, 2017
• Last Updated: September 14, 2018
• Results First Posted: August 16, 2018

Record last verified: 2018-08

Locations

US (1)