Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Adult Solid Neoplasm, Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT00499135
Run by: National Cancer Institute (NCI)
People needed: 25
Starts: 2007-05-22
Expected to finish: 2014-05-14
Last updated by the study team: 2017-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed renal cell cancer; or other solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard curative therapy exists
For the renal cell cancer subset, a component of clear cell histology is required
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
Life expectancy > 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Leukocytes >= 3,000/mm\^3
Absolute neutrophil count (ANC) >= 1,500/mm\^3
Platelet count >= 100,000/mm\^3
Hemoglobin >= 9 g/dL
Serum calcium =< 12.0 mg/dL
Total bilirubin normal
Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times upper limit of normal (ULN), unless subjects have liver metastases, in which case both AST and ALT must be =< 5 x ULN
Creatinine =< 2 times ULN OR creatinine clearance >= 40 mL/min for patients with creatinine levels above 2 x institutional normal
All patients need to be willing to undergo planned pharmacodynamic assessments, including serial PET imaging, plasma markers, and pharmacokinetic sampling
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

Patients who have had chemotherapy, radiotherapy, experimental therapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered (to grade < 1 or baseline) from clinically significant adverse events due to agents administered more than 4 weeks earlier (alopecia and fatigue excluded); clinical significance to be determined by investigator
Patients may not be receiving any other investigational agents
No prior treatment with an anti-VEGF agent allowed
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
Patients with QTc prolongation (defined as a QTc interval greater than 500 msec) or other significant electrocardiogram (ECG) abnormalities (per investigator discretion) are excluded
Patients with poorly controlled hypertension (systolic blood pressure of 140 mm Hg or higher or diastolic blood pressure of 90 mm Hg or higher) are ineligible
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded
Patients with any of the following conditions are excluded:
Serious or nonhealing wound, ulcer, or bone fracture
Abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within the past 28 days
Cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry
History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
History of pulmonary embolism within the past 12 months
Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; patients with a history of hypothyroidism are eligible provided they are currently euthyroid
Patients with known brain metastases
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements are ineligible
Pregnant or breastfeeding
No concurrent therapeutic doses of coumarin-derivative anticoagulants, such as warfarin; Concurrent doses =< 2 mg/day allowed for prophylaxis of thrombosis, Concurrent low molecular weight heparin allowed provided prothrombin time (PT) international normalized ratio ( INR) =< 1.5
No concurrent agents with proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, and flecainide acetate)
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Where it is running

University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.