Sunitinib Before and After Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed By Surgery

Phase 1

Terminated

• Conditions: Kidney Cancer
• Interventions: Drug: sunitinib malate; Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: western blotting; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

• Registration Number: NCT00747305
• Lead Sponsor: Harry Drabkin

Brief Summary

RATIONALE: Sunitinib 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well sunitinib works when given before and after surgery in treating patients with metastatic kidney cancer that can be removed by surgery.

Detailed Description

OBJECTIVES:

* To describe the gene expression of VEGF and non-VEGF angiogenic growth factor genes in kidney cancer specimens from patients with metastatic renal cell carcinoma treated with sunitinib malate.

* To describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors and clinical efficacy of this drug, as measured by response, duration of response, and time to progression in these patients.

OUTLINE: Patients receive oral sunitinib malate once daily for 8 weeks. Within 2 weeks after completion of neoadjuvant chemotherapy, patients undergo a nephrectomy and evaluation for response to therapy. Beginning 4-8 weeks after surgery patients resume oral sunitinib malate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Patients with disease progression after 8 weeks of adjuvant treatment receive treatment off study with other agents.

Viable (non-necrotic) tumor and non-tumor kidney tissue samples are obtained at the time of nephrectomy for correlative biomarker studies. Tissue samples are analyzed for gene expression of VEGF and non-VEGF angiogenic factors by real-time RT-PCR, western blot, and/or IHC. Blood samples are obtained at baseline and at 4 and 8 weeks for evaluation of circulating levels of VEGF and selected chemokines.

After completion of study therapy, patients are followed monthly.

Study Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Study Start: 2008-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib	adjuvant therapy	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	western blotting	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	immunohistochemistry staining method	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	reverse transcriptase-polymerase chain reaction	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	gene expression analysis	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	neoadjuvant therapy	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	laboratory biomarker analysis	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	therapeutic conventional surgery	Sunitinib will be administered for 8 weeks prior to sugery
Sunitinib	sunitinib malate	Sunitinib will be administered for 8 weeks prior to sugery

Primary Outcome Measures

Name	Time	Method
Describe the gene expression of VEGF and non-VEGF from eligible patients being treatment with Sunitinib.	at various points throughout the study duration
Describe the association between quantitative gene expression levels of VEGF and non-VEGF angiogenic factors with the clinical efficacy of Sunitinib as measured by response, duration or response and time to progression	at various points throughout the study duration

Trial Locations

Locations (1)

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States