Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer

Phase 2

Completed

Conditions: Stage II Renal Cell Cancer
Clear Cell Renal Cell Carcinoma
Stage I Renal Cell Cancer
Stage III Renal Cell Cancer

Interventions: Drug: pazopanib hydrochloride
Procedure: therapeutic conventional surgery

Registration Number: NCT01158521

Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary: RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works when given before surgery in treating patients with kidney cancer.

Detailed Description: PRIMARY OBJECTIVES:

I. To determine the rate of partial nephrectomy in patients with primary renal tumors otherwise requiring radical nephrectomy after neoadjuvant pazopanib treatment.

SECONDARY OBJECTIVES:

I. To determine the safety, tumor diameter/volume change, conversion of hilar to non-hilar tumors and surgical morbidity of neoadjuvant pazopanib for renal cell carcinoma (RCC).

OUTLINE:

Patients receive oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.

After completion of study treatment, patients are followed up for 1 year.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	therapeutic conventional surgery	Patients receive oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Arm I	pazopanib hydrochloride	Patients receive oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy	Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks.	The primary end point was the percentage of patients who could undergo partial nephrectomy after pazopanib therapy. A reduction in tumor size, with pazopanib treatment, may permit the use of a partial nephrectomy, as opposed to a radical nephrectomy. This would help preserve additional vascularized parenchyma.

Secondary Outcome Measures

Name	Time	Method
Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment.	After 8 to 16-weeks of pazopanib therapy and 7 day washout prior to surgery.	Measurement of total parenchymal tissue that could be saved with pazopanib therapy and subsequent surgery, which was performed via a volumetric analysis of CT images.
Change in Tumor Diameter	At the conclusion of 8 to 16-week treatment with pazopanib therapy.	Median (cm) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR	At the end of 8 to 16-weeks of treatment	Efficacy of pazopanib was evaluated via the Response Evaluation Criteria in Solid Tumors, version 1.1. Assessed by MRI. Definitions of response include Complete Response (CR), Disappearance of target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR
Surgical Morbidity	post-surgery	Conversion of tumor post therapy so that there is \< 10% risk that a partial nephrectomy would be associated with a high risk of significant postoperative morbidity (e.g. conversion of tumor post therapy to ≥ 3 mm away from renal hilum (main renal artery, renal vein, or primary branches)
Reduction in Tumor Volume After Treatment	After 8 to 16-weeks of pazopanib treatment	Median (cm\^3) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment).

Trial Locations

Locations (2): Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States