Neoadjuvant Pazopanib in Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2017-02-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: GlaxoSmithKline

Criteria

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

• The Eastern Cooperative Oncology Group (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 ≥ 90 mmHg 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 Corrected QT Interval (QTc) >480 msec or other clinically significant baseline ECG abnormality