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Neoadjuvant Pazopanib in Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01361113
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : May 10, 2017
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Pazopanib Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2011
Actual Primary Completion Date : January 7, 2015
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib

Arms and Interventions
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Arm Intervention/treatment
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
 Drug: Pazopanib
800 mg orally once daily for 8 weeks, prior to nephrectomy
Other Name: Votrient


Outcome Measures
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Primary Outcome Measures :
  1. Response Rate [ Time Frame: 8 weeks after neoadjuvant treatment ]

    Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma.

    Evaluation of Target Lesions using RECIST 1.1 Criteria:

    Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to <10mm.

    Partial response (PR)-At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD.



Secondary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ Time Frame: 2 years ]
    Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.

  2. Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib [ Time Frame: 14 weeks ]
    Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.

  3. Number of Participants With Adverse Events Related to Treatment. [ Time Frame: 9 weeks ]

    Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0).

    Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

    Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.

    Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361113


Locations
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United States, North Carolina
North Carolina Cancer Hospital (UNC)
Chapel Hill, North Carolina, United States, 27599
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
GlaxoSmithKline
Investigators
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Principal Investigator: William Kim, MD UNC Lineberger Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01361113    
Other Study ID Numbers: LCCC 1028
11-0457 ( Other Identifier: UNC IRB )
First Posted: May 26, 2011    Key Record Dates
Results First Posted: May 10, 2017
Last Update Posted: April 25, 2018
Last Verified: March 2018
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Renal Cell Carcinoma
RCC
Votrient
Pazopanib
Nephrectomy
 Neoadjuvant
Phase II
LCCC 1028
Lineberger Comprehensive Cancer Center
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases