NCT01361113

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 10, 2017

Completed
Last Updated

April 25, 2018

Status Verified

March 1, 2018

Enrollment Period

3.6 years

First QC Date

May 23, 2011

Results QC Date

March 30, 2017

Last Update Submit

March 27, 2018

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell CarcinomaRCCVotrientPazopanibNephrectomyNeoadjuvantPhase IILCCC 1028Lineberger Comprehensive Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    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.

    8 weeks after neoadjuvant treatment

Secondary Outcomes (3)

  • Recurrence Free Survival (RFS)

    2 years

  • Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib

    14 weeks

  • Number of Participants With Adverse Events Related to Treatment.

    9 weeks

Study Arms (1)

Single Arm Neoadjuvant Pazopanib

OTHER

Pazopanib 800 mg PO once daily for 8 weeks

Drug: Pazopanib

Interventions

PazopanibDRUG

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

Also known as: Votrient
Single Arm Neoadjuvant Pazopanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Carolina Cancer Hospital (UNC)

Chapel Hill, North Carolina, 27599, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Robin V. Johnson
Organization
UNC Lineberger Comprehensive Cancer Center
Robin_V_Johnson@med.unc.edu
919-966-1125

Study Officials

  • William Kim, MD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 26, 2011

Study Start

June 1, 2011

Primary Completion

January 7, 2015

Study Completion

February 15, 2017

Last Updated

April 25, 2018

Results First Posted

May 10, 2017

Record last verified: 2018-03

Locations

US(2)