Renal Cell Carcinoma Clinical Trial
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
Verified date | March 2018 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 21 |
Est. completion date | February 15, 2017 |
Est. primary completion date | January 7, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | North Carolina Cancer Hospital (UNC) | Chapel Hill | North Carolina |
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Recurrence Free Survival (RFS) | 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 years | |
Secondary | Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib | Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response. | 14 weeks | |
Secondary | Number of Participants With Adverse Events Related to Treatment. | 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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