Neoadjuvant Pazopanib in Renal Cell Carcinoma

NCT ID: NCT01361113

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-02-15

Brief 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).

Detailed 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 Response Evaluation Criteria in Solid Tumors (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).

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm Neoadjuvant Pazopanib

Pazopanib 800 mg PO once daily for 8 weeks

Group Type: OTHER

Pazopanib

Intervention Type: DRUG

800 mg orally once daily for 8 weeks, prior to nephrectomy

Interventions

Pazopanib

800 mg orally once daily for 8 weeks, prior to nephrectomy

Intervention Type: DRUG

Other Intervention Names

Votrient

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Kim, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

North Carolina Cancer Hospital (UNC)

Chapel Hill, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://cancer.med.unc.edu/

Lineberger Comprehensive Cancer Center

Other Identifiers

11-0457

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 1028

Identifier Type: -

Identifier Source: org_study_id