Sunitinib Malate in Treating Patients With Kidney Cancer

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Brief summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.

Detailed description

OBJECTIVES: Primary * To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer. Secondary * To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients. * To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment. * To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients. OUTLINE: This is a multicenter study. Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.

Christopher Montemagno, Jérôme Durivault, Cécile Gastaldi, Maeva Dufies, Valérie Vial et al. (13 authors)

Molecular Oncology2023-02-219 citations

10.1002/1878-0261.13401

Resistance to lysosomotropic drugs used to treat kidney and breast cancers involves autophagy and inflammation and converges in inducing CXCL5

Sandy Giuliano, Maeva Dufies, Papa Diogop Ndiaye, Julien Viotti, Delphine Borchiellini et al. (16 authors)

Theranostics2019-01-0151 citations

10.7150/thno.29093

Impact of pharmacokinetics (PK) of sunitinib (SU) and its metabolite SU12662 on clinical outcome and toxicity in metastatic renal cell cancer (mRCC) patients.

Nicolas Martin, Delphine Borchiellini, Julien Viotti, Emmanuel Chamorey, G. Milano et al. (6 authors)

Journal of Clinical Oncology2017-02-201 citations

10.1200/jco.2017.35.6_suppl.506

Interventions

DRUGsunitinib malate

OTHERlaboratory biomarker analysis

OTHERpharmacological study

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease requiring first-line treatment with sunitinib malate * No prior therapy for metastatic disease * No symptomatic or uncontrolled cerebral metastasis PATIENT CHARACTERISTICS: * Affiliation to the French Social insurance * Life expectancy ≥ 3 months * No heart failure * No chronic unstable disease * No long QT interval * No history of another primary cancer * No severe, uncontrolled acute infection * No severe, uncontrolled hypertension * No psychological disorder PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame
Disease response	5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment	5 years

Secondary

Measure	Time frame
Disease-free survival	up to 5 years
Overall survival	up to 5 years
Length of the response	up to 5 years

Countries

France

Outcome results

None listed