Mercy Health Northside Campus and Reviews on Saundra Blanchard

Report Identification

Unique Protocol ID:	NCI-2009-00534
Brief Title:	Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed Past Surgery (ASSURE)
Official Championship:	ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Secondary IDs:	NCI-2009-00534 [Registry Identifier: CTRP (Clinical Trial Reporting Program)] Can-NCIC-E2805 SWOG-E2805 ECOG-E2805 CDR0000478976 CALGB-E2805 E2805 [ECOG-ACRIN Cancer Research Group] E2805 [CTEP] U10CA180820 [U.S. NIH Grant/Contract] U10CA021115 [U.Due south. NIH Grant/Contract]

Study Status

Tape Verification:	March 2015
Overall Status:	Active, non recruiting
Study Start:	April 2006
Primary Completion:	April 2016 [Anticipated]
Study Completion:
First Submitted:	May sixteen, 2006
First Submitted that Met QC Criteria:	May 16, 2006
First Posted:	May 17, 2006 [Judge]
Last Update Submitted that Met QC Criteria:	April 15, 2015
Last Update Posted:	April sixteen, 2015 [Estimate]

Oversight

U.S. FDA-regulated Drug:
U.Due south. FDA-regulated Device:
Data Monitoring:	Yes

Study Clarification

Brief Summary:	This randomized phase Three trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed past surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells past blocking some of the enzymes needed for cell growth and past blocking claret flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not notwithstanding known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.
Detailed Clarification:	PRIMARY OBJECTIVES: I. To demonstrate an improvement in affliction-free survival in locally advanced renal prison cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy. SECONDARY OBJECTIVES: I. To compare overall survival of patients randomized to each of the two regimens with placebo. Two. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population. 3. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, claret and urine as predictors of illness-free survival and of therapeutic benefit. Iv. To prospectively collect tumor and biological specimens to appraise their characteristics and associations: the frequency of oncogene and tumor suppressor cistron mutations as predictors of disease-free survival and therapeutic benefit. 5. To prospectively collect tumor and biological specimens to appraise their characteristics and associations: tumor and genetic polymorphisms as predictors of affliction-free survival and therapeutic benefit. VI. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acrid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit. 7. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady country concentrations of sorafenib and sunitinib in selected patients. 8. To study the effect of vascular endothelial growth cistron (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors. Nine. To prospectively assess patient-reported fatigue in lodge to compare the magnitude and trajectory of fatigue amid renal cell carcinoma (RCC) patients randomized to adjuvant sunitinib (Arm A) or sorafenib (Arm B) to placebo (Arm C). (Quality of life objectives) X. To evaluate the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-Short Course (SF)1, a newly developed country-of-the-science PROMIS measure for fatigue and to calibrate the PROMIS Fatigue-SF1 with the established, validated FACIT-Fatigue scale. (Quality of life objectives) OUTLINE: Patients are randomized to ane of 3 treatment arms. ARM A: Kickoff 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks and placebo sorafenib tosylate PO QD or twice daily (BID) for 6 weeks. ARM B: Kickoff 4-12 weeks post-obit radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for 4 weeks followed. ARM C: Starting time 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate every bit in Arm A and placebo sunitinib malate as in Arm B. In all arms, treatment repeats every half dozen weeks for 9 courses in the absence of affliction progression or unacceptable toxicity. Subsequently completion of study handling, patients are followed up every iii months for two years, every 6 months for three years, and then every 12 months for 5 years.

Conditions

Weather:	Clear Prison cell Renal Jail cell Carcinoma Phase I Renal Cell Cancer Stage Ii Renal Cell Cancer Phase III Renal Prison cell Cancer
Keywords:

Study Pattern

Written report Type:	Interventional
Chief Purpose:	Treatment
Written report Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Artillery:	3
Masking:	Double (Participant, Investigator)
Allotment:	Randomized
Enrollment:	1923 [Anticipated]

Artillery and Interventions

Arms Assigned Interventions Experimental: Arm A (sunitinib malate, placebo) Beginning 4-12 weeks following radical or fractional nephrectomy, patients receive sunitinib malate PO QD for 4 weeks and placebo sorafenib tosylate PO QD or BID for half-dozen weeks. Laboratory Biomarker Analysis Correlative studies Placebo Given PO Other Names: placebo therapy PLCB sham therapy Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Sunitinib Malate Given PO Other Names: SU011248 SU11248 sunitinib Sutent Experimental: Arm B (sorafenib tosylate, placebo) Outset 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate PO QD or BID for 6 weeks and placebo sunitinib malate PO QD for iv weeks followed. Laboratory Biomarker Assay Correlative studies Placebo Given PO Other Names: placebo therapy PLCB sham therapy Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Sorafenib Tosylate Given PO Other Names: BAY 43-9006 Tosylate BAY 54-9085 Nexavar sorafenib Placebo Comparator: Arm C (placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate as in Arm A and placebo sunitinib malate as in Arm B. Laboratory Biomarker Analysis Correlative studies Placebo Given PO Other Names: placebo therapy PLCB sham therapy Quality-of-Life Cess Ancillary studies Other Names: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures:
1.	Disease-free survival (DFS) [ Fourth dimension Frame: Time from randomization to recurrence, development of second primary cancer, or expiry from whatever crusade, assessed up to 10 years ] A weighted mixture of the log chance rates was used to guess the constructive (increased) take a chance charge per unit on the experimental arm. Using this adjusted alternative hazard rate, the target is instead a reduction in the hazard rate of 20% for DFS events when comparing each experimental arm to placebo.
Secondary Issue Measures:
i.	Changes in left ventricular ejection fraction (LVEF) pass up in patients treated with sunitinib malate or sorafenib tosylate [ Time Frame: Baseline to half dozen months ] LVEF decline defined as LVEF below the institutional lower limit of normal, where the drop is at to the lowest degree 16% from baseline.
two.	DFS among patients with articulate cell histology [ Time Frame: Upward to 13 years ] The sequentially rejective method will be used for this analysis.
3.	Differences in fatigue assessed by FACIT Fatigue Subscale [ Time Frame: Baseline to up to 22 weeks ] For each of the two instruments, descriptive statistics at each timepoint, including Cronbach's blastoff, will be provided. Repeated measures analyses will be used to examine the treatment and time furnishings on scores. Spearman's correlation coefficient will be used to explore associations betwixt scores on the FACIT Fatigue subscale and scores on the PROMIS Fatigue-SF1.
four.	Frequency of clinically significant congestive heart failure (CHF) grade 3 or higher using the Common Terminology Criteria for Agin Events version 4.0 [ Fourth dimension Frame: Baseline to upwards to 8 weeks after final treatment ] To examine the effect of browse frequency on preventing CHF, the incidence of CHF after MUGA scan intervals of 3 months and 6 months volition be described.
5.	Overall survival [ Time Frame: From the date of registration to upwards to10 years ]
6.	Psychometric backdrop assessed by the PROMIS Fatigue-SF1 measure [ Fourth dimension Frame: Up to week 22 ] For each of the two instruments, descriptive statistics at each timepoint, including Cronbach's alpha, volition exist provided. Repeated measures analyses volition be used to examine the treatment and fourth dimension effects on scores. Spearman's correlation coefficient volition be used to explore associations between scores on the FACIT Fatigue subscale and scores on the PROMIS Fatigue-SF1.
vii.	Browse frequency in preventing CHF [ Time Frame: Up to 12 months ] The incidence of CHF after MUGA scan intervals of 3 months and 6 months will be described along with changes in LVEF over these intervals.

Eligibility

Minimum Age:	eighteen Years
Maximum Historic period:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Pre-surgical criteria: Patients must have primary-intact renal jail cell carcinoma, eligible for nephrectomy with curative intent Tumors >= 4 cm AND/OR macroscopic fully resectable nodes AND/OR surgically resectable renal vein thrombus AND/OR surgically resectable inferior vena caval thrombus past radiologic criteria to be clinically >= pT1bNany (resectable) M0 affliction Multifocal ipsilateral renal cell carcinoma is allowed provided fully resectable and does not exceed inclusion criteria Patients must have no history of distant metastases No prior anti-cancer therapy for renal cell carcinoma is permitted in either the adjuvant or neoadjuvant setting; this includes metastectomy for renal prison cell carcinoma, or radiation therapy to the renal bed Patients must not have other current malignancies, other than basal jail cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-gratuitous for >= five years prior to the fourth dimension of registration Patients must have no serious intercurrent illness including, but non express to, the following: clinically significant cardiovascular disease (east.1000. uncontrolled hypertension, myocardial infarction, unstable angina); New York Heart Association course II or greater congestive heart failure; serious cardiac arrhythmia requiring medication; form Two or greater peripheral vascular disease; or psychiatric illness/social situations that would limit compliance with written report requirements Patients must not take whatever of the following within the half-dozen months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery featherbed graft, symptomatic congestive centre failure, cerebrovascular blow or transient ischemic set on, or pulmonary embolism Patient must not have ongoing ventricular cardiac dysrhythmias of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade >= ii; patients with a history of serious ventricular arrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF] >= 3 beats in a row) are also excluded; additionally, patients with ongoing atrial fibrillation are non eligible Patients must have corrected QT (QTc) interval < 500 msec on baseline electrocardiogram (EKG) Patient must non have hypertension that cannot be controlled by medications (>= diastolic claret pressure 100 mm Hg despite optimal medical therapy) Patient must not accept pre-existing thyroid aberration with thyroid stimulating hormone that cannot be maintained in the normal range with medication If female, patient must not be significant or breastfeeding; all females of childbearing potential must accept a blood exam or urine study within ii weeks prior to pre-registration to rule out pregnancy; if pre-registration occurs prior to surgery, the blood or urine report must be repeated within 2 weeks prior to randomization to rule out pregnancy; (notation: should a woman go significant while participating in this study, she should inform her treating md immediately) Women of child-bearing potential and men must concord to utilize an accustomed and effective method of contraception prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating doc immediately; if a man impregnates a woman while participating in this study, he should inform his treating md immediately every bit well Patients with known human being immunodeficiency virus (HIV) are excluded ELIGIBILITY CRITERIA Following RADICAL OR PARTIAL NEPHRECTOMY The engagement of randomization must be less than 12 weeks afterward the appointment of surgery; patients must have recovered from any surgical related complications Inside 4 weeks prior to randomization, patients must meet preoperative eligibility requirements Patients must have histologically or cytologically confirmed renal prison cell carcinoma. Using 2002 (American Joint Committee on Cancer [AJCC] 6th edition) TNM Staging, patients must be one of the post-obit: pT1b G3-4 N0 (or pNX where clinically N0) M0 pT2 M (whatever) N0 (or pNX where clinically N0) M0 pT3 K (any) N0 (or pNX where clinically N0) M0 pT4 K (any) N0 (or pNX where clinically N0) M0 or T (any) G (any) Due north+ (fully resected) M0 Patients with microvascular invasion of the renal vein of whatsoever grade or stage (as long every bit M0) are also eligible Patients must have undergone a total surgical resection (radical nephrectomy or partial nephrectomy) by either open up or laparoscopic technique; clinical evidence of lymph node positivity requires removal of all clinically positive nodes; surgeons should designate extent of node autopsy; all surgical specimens must accept negative margins; patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive) Patients must non have collecting duct carcinomas or medullary carcinomas Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-one Patients must have an absolute baseline left ventricular ejection fraction (LVEF) of >= 50% by multigated acquisition (MUGA) scan within iv weeks prior to randomization Patients must have paraffin-embedded tumor specimen available for cardinal cadre review of tumor histology and other correlative studies; tumor samples will be shipped every bit specified Patients must take no evidence of residual or metastatic renal prison cell cancer as documented on computed tomography (CT) scans of the chest, abdomen, and pelvis, all with oral and intravenous (IV) dissimilarity (magnetic resonance imaging [MRI] scans of the abdomen and pelvis with gadolinium and a not-contrast CT of the chest may exist substituted if patient is not able to take CT scans with intravenous dissimilarity); patients unable to tolerate either gadolinium or 4 contrast should non participate in this report (limitations to a patient's renal role should be taken into consideration when screening for this study) Scans must be obtained within iv weeks of randomization; changes on these scans that are felt to exist mail surgical must be documented Patients without reported lymph nodes in the resected surgical specimen and a reported pathologic stage (post-nephrectomy) of pNX MUST undergo a post-operative contrast-enhanced CT scan (or MRI with gadolinium) within 4 weeks of randomization to certificate that in that location is no evidence of balance disease Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), St John'south Wort, ketoconazole, dexamethasone, the dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice inside two weeks of randomization and during the form of therapy; (medications are not prohibited unless listed above); topical and inhaled steroids are permitted Patients must non receive any other investigational anti-cancer agents during the period on written report Patients must non have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics Accented granulocyte count (AGC) >= 1,500/mm^iii Platelet count >= 100,000/mm^three Serum creatinine =< 2.0 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 30 mL/min (neither drug is cleared by the kidney) Total bilirubin =< 1.5 10 upper limit of normal (ULN) Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< ii.five x ULN Patients must be able to swallow pills

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References

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Source: https://www.clinicaltrials.gov/ct2/history/NCT00326898?V_792=View

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