- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01361113
Neoadjuvant Pazopanib in Renal Cell Carcinoma
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- North Carolina Cancer Hospital (UNC)
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
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800 mg orally once daily for 8 weeks, prior to nephrectomy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate
Time Frame: 8 weeks after neoadjuvant treatment
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence Free Survival (RFS)
Time Frame: 2 years
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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.
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2 years
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Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib
Time Frame: 14 weeks
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Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.
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14 weeks
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Number of Participants With Adverse Events Related to Treatment.
Time Frame: 9 weeks
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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. |
9 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: William Kim, MD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1028
- 11-0457 (Other Identifier: UNC IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
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National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
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National Cancer Institute (NCI)Canadian Cancer Trials GroupActive, not recruitingUnresectable Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell Carcinoma | Metastatic Papillary Renal Cell Carcinoma | Locally Advanced Papillary Renal Cell CarcinomaUnited States, Canada
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Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
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Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
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Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
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Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
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Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
Clinical Trials on Pazopanib
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Cure HHTUniversity of North CarolinaNot yet recruitingEpistaxis | Hereditary Hemorrhagic Telangiectasia
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National Cancer Institute (NCI)Active, not recruitingClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v7United States
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Illinois CancerCare, P.C.TerminatedNon Small Cell Lung CancerUnited States
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Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedMetastatic Renal Cell Carcinoma
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Institut Claudius RegaudNovartisTerminatedMetastatic Cancer (Different Solid Tumour Types)France
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Gynecologic Oncology GroupGlaxoSmithKlineWithdrawnUterine Leiomyosarcoma
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Samsung Medical CenterCompletedRefractory Solid TumorsKorea, Republic of
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Spanish Oncology Genito-Urinary GroupCompletedMetastatic Renal Cell CarcinomaSpain
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GlaxoSmithKlineCompletedMacular DegenerationUnited States
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Samsung Medical CenterCompletedLocally Advanced or Metastatic Non-clear Cell Type Renal Cell CarcinomaKorea, Republic of