Trial Outcomes & Findings for Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer (NCT NCT01158521)

Last Updated: 2018-09-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks.

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib Hydrochloride Before Surgery in Treating Patients With Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Age, Continuous	64 years n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	21 Participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: Partial nephrectomy performed after 8 to 16-weeks of pazopanib prescription. The median interval from treatment start to surgery was 10.6 weeks.

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Number of Participants Who Could Undergo Partial Nephrectomy After Pazopanib Therapy	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Residual Vascularized Parenchyma After Pazopanib Therapy and Subsequent Surgery Relative to Pre-therapy Assessment.	173 cm^3 Interval 127.0 to 238.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Change in Tumor Diameter	5.5 cm Interval 1.8 to 8.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Target Lesions: Complete Response, Partial Response, Overall Response (OR)=CR+PR	10 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Surgical Morbidity	16 Participants

SECONDARY outcome

Timeframe: After 8 to 16-weeks of pazopanib treatment

Median (cm\^3) tumor size reduction after pazopanib treatment, relative to baseline (i.e., before treatment).

Outcome measures

Outcome measures
Measure	Arm I n=25 Participants Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Reduction in Tumor Volume After Treatment	92 cm^3 Interval 50.0 to 118.0

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group n=25 participants at risk Patients receive oral pazopanib hydrochloride once daily for up to 16 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. pazopanib hydrochloride: Oral pazopanib hydrochloride once daily for up to 16 weeks in the absence of disease progression or unacceptable toxicity. therapeutic conventional surgery: Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
Vascular disorders Hypertension	16.0% 4/25
Hepatobiliary disorders Elevated Liver Enzymes	20.0% 5/25
General disorders Fatigue	76.0% 19/25
Blood and lymphatic system disorders Thrombocytepenia	4.0% 1/25
Hepatobiliary disorders Liver enzymes	48.0% 12/25
Gastrointestinal disorders Diarrhea	52.0% 13/25
Blood and lymphatic system disorders Thrombocytopenia	48.0% 12/25
General disorders Taste Change	48.0% 12/25
Gastrointestinal disorders Nausea/vomiting	48.0% 12/25
Gastrointestinal disorders Mucositis	44.0% 11/25
General disorders Hair Depigmentation	44.0% 11/25
Psychiatric disorders Anorexia	44.0% 11/25
Skin and subcutaneous tissue disorders Hand-foot syndrome	36.0% 9/25
Renal and urinary disorders Increased Creatinine	24.0% 6/25
Metabolism and nutrition disorders Weight Loss	24.0% 6/25
Hepatobiliary disorders Increased Bilirubin	20.0% 5/25

Additional Information

Dr. Brian Rini

Cleveland Clinic

Phone: (216) 444-9567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place