This trial is active, not recruiting.

Condition renal cell carcinoma
Treatment pazopanib
Phase phase 2
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator GlaxoSmithKline
Start date May 2011
End date June 2017
Trial size 21 participants
Trial identifier NCT01361113, 11-0457, LCCC 1028


This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Single arm trial
pazopanib Votrient
800 mg orally once daily for 8 weeks, prior to nephrectomy

Primary Outcomes

Response rate
time frame: 8 weeks after neoadjuvant treatment

Secondary Outcomes

Recurrence Free Survival (RFS)
time frame: 2 years
Altered surgical approach after treatment with pazopanib
time frame: 14 weeks
Number of participants with adverse events
time frame: 14 weeks
Predictive molecular markers in response to treatment with pazopanib
time frame: 1 year
Exploratory Analysis of Objective Response and Recurrence Free Survival rates
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥ 18 years with radiographic evidence of nonmetastatic renal cell carcinoma - Histological verification of clear cell renal cell carcinoma (-Clinical stage 2 (7 cm) or greater with localized disease - No evidence of extranodal metastatic disease - Appropriate candidate for surgery - ECOG Performance status of 0-1 - Adequate organ function - Serum calcium, magnesium, potassium within normal limits, or if outside of normal limits, must be deemed clinically insignificant by the Investigator. - No known coagulopathy - Ability to read and follow instructions - Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of pazopanib treatment and both men and women must be willing to use adequate contraception. - Able to provide written, informed consent - Blood and urine samples must be provided from all subjects for biomarker analysis before and during treatment with pazopanib Exclusion Criteria - Known or suspected allergy to pazopanib - Inability to swallow or retain oral medication - Prior malignancy Exception: Subjects who have had another malignancy and have been disease-free for three years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. - Unable or unwilling to discontinue use of prohibited medications at least 7 days prior to the first dose of study drug and for the duration of the study. - Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. - History of any one or more cardiovascular conditions within the past 6 months - Hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg OR diastolic blood pressure (DBP) of ≥ 90mmHg in spite of optimal medical management. - Evidence of active bleeding or bleeding diathesis. - Any serious and/or unstable pre-existing medical (especially hepatic disease), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. - Prior major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major). - Pregnant or breastfeeding; breastfeeding may not resume for 14 days after the last dose of pazopanib - Prior treatment with any of the following anti-cancer therapies for treatment of their RCC: - radiation therapy, surgery or tumor embolization - chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy - Baseline QTc>480 msec or other clinically significant baseline ECG abnormality

Additional Information

Official title Neoadjuvant Pazopanib: A Phase II Study to Evaluate the Effect on Disease Response and Recurrence and to Establish Predictive Biomarkers of Drug Activity in Renal Cell Carcinoma
Principal investigator William Kim, MD
Description The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via RECIST1.1. The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.