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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

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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

The primary objective of this study is to determine the objective response rate Complete
Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 12 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).

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Determine the objective response rate (CR+PR) using RECIST 1.1 at 12 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma

Outcome Time Frame:

12 weeks after neoadjuvant treatment

Safety Issue:


Principal Investigator

Kimryn Rathmell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

LCCC 1028



Start Date:

May 2011

Completion Date:

June 2015

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • RCC
  • Votrient
  • Pazopanib
  • Nephrectomy
  • Neoadjuvant
  • Phase II
  • LCCC 1028
  • Lineberger Comprehensive Cancer Center
  • Carcinoma
  • Carcinoma, Renal Cell



Duke University Medical Center Durham, North Carolina  27710
Carolinas HealthCare System Charlotte, North Carolina  
Medical University of South Carolina (MUSC) Charleston, South Carolina  29425
Weill Cornell Medical College New York, New York  10021
North Carolina Cancer Hospital (UNC) Chapel Hill, North Carolina  27599