Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01158222
First received: July 6, 2010
Last updated: February 8, 2013
Last verified: February 2013
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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: Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity as assessed by Common Terminology Criteria for Adverse Events(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 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:
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
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: | February 8, 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 June 17, 2013