Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/20/2016
Start Date:April 2006
End Date:August 2015

Use our guide to learn which trials are right for you!

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

This randomized phase III 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 by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to
the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor
cells that remain after surgery. It is not yet known whether sunitinib malate is more
effective than sorafenib tosylate or placebo in treating kidney cancer.

PRIMARY OBJECTIVES:

I. To demonstrate an improvement in disease-free survival in locally advanced renal 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.

II. To further define the toxicity of prolonged administration of sunitinib or sorafenib in
this patient population.

III. To prospectively collect tumor and biological specimens to assess their characteristics
and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine
as predictors of disease-free survival and of therapeutic benefit.

IV. To prospectively collect tumor and biological specimens to assess their characteristics
and associations: the frequency of oncogene and tumor suppressor gene mutations as
predictors of disease-free survival and therapeutic benefit.

V. To prospectively collect tumor and biological specimens to assess their characteristics
and associations: tumor and genetic polymorphisms as predictors of disease-free survival and
therapeutic benefit.

VI. To prospectively collect tumor and biological specimens to assess their characteristics
and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome
and of therapeutic benefit.

VII. To prospectively collect tumor and biological specimens to assess their characteristics
and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady
state concentrations of sorafenib and sunitinib in selected patients.

VIII. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on
circulating endothelial cells and circulating endothelial progenitors.

IX. To prospectively assess patient-reported fatigue in order to compare the magnitude and
trajectory of fatigue among 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 Form (SF)1, a newly developed state-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 1 of 3 treatment arms.

ARM A: Beginning 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: Beginning 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 4 weeks
followed.

ARM C: 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.

In all arms, treatment repeats every 6 weeks for 9 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then every 12 months for 5 years.

Inclusion Criteria:

- Pre-surgical criteria:

- Patients must have primary-intact renal 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 by radiologic criteria to be clinically >= pT1bNany (resectable) M0
disease

- 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 cell carcinoma,
or radiation therapy to the renal bed

- Patients must not have other current malignancies, other than basal 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-free for >= 5 years prior to the time of registration

- Patients must have no serious intercurrent illness including, but not limited to, the
following: clinically significant cardiovascular disease (e.g. uncontrolled
hypertension, myocardial infarction, unstable angina); New York Heart Association
grade II or greater congestive heart failure; serious cardiac arrhythmia requiring
medication; grade II or greater peripheral vascular disease; or psychiatric
illness/social situations that would limit compliance with study requirements

- Patients must not have any of the following within the 6 months prior to study drug
administration: myocardial infarction, severe/unstable angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident
or transient ischemic attack, 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 >= 2; 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 not eligible

- Patients must have corrected QT (QTc) interval < 500 msec on baseline
electrocardiogram (EKG)

- Patient must not have hypertension that cannot be controlled by medications (>=
diastolic blood pressure 100 mm Hg despite optimal medical therapy)

- Patient must not have pre-existing thyroid abnormality with thyroid stimulating
hormone that cannot be maintained in the normal range with medication

- If female, patient must not be pregnant or breastfeeding; all females of childbearing
potential must have a blood test or urine study within 2 weeks prior to
pre-registration to rule out pregnancy; if pre-registration occurs prior to surgery,
the blood or urine study must be repeated within 2 weeks prior to randomization to
rule out pregnancy; (note: should a woman become pregnant while participating in this
study, she should inform her treating physician immediately)

- Women of child-bearing potential and men must agree to use an accepted 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 physician immediately; if a man impregnates a woman while
participating in this study, he should inform his treating physician immediately as
well

- Patients with known human immunodeficiency virus (HIV) are excluded

- ELIGIBILITY CRITERIA FOLLOWING RADICAL OR PARTIAL NEPHRECTOMY

- The date of randomization must be less than 12 weeks after the date of surgery;
patients must have recovered from any surgical related complications

- Within 4 weeks prior to randomization, patients must meet preoperative eligibility
requirements

- Patients must have histologically or cytologically confirmed renal cell carcinoma.
Using 2002 (American Joint Committee on Cancer [AJCC] 6th edition) TNM Staging,
patients must be one of the following:

- pT1b G3-4 N0 (or pNX where clinically N0) M0

- pT2 G (any) N0 (or pNX where clinically N0) M0

- pT3 G (any) N0 (or pNX where clinically N0) M0

- pT4 G (any) N0 (or pNX where clinically N0) M0 or

- T (any) G (any) N+ (fully resected) M0

- Patients with microvascular invasion of the renal vein of any grade or
stage (as long as M0) are also eligible

- Patients must have undergone a full surgical resection (radical nephrectomy
or partial nephrectomy) by either open or laparoscopic technique; clinical
evidence of lymph node positivity requires removal of all clinically
positive nodes; surgeons should designate extent of node dissection; all
surgical specimens must have 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 not have collecting duct carcinomas or medullary carcinomas

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0-1

- Patients must have an absolute baseline left ventricular ejection fraction (LVEF) of
>= 50% by multigated acquisition (MUGA) scan within 4 weeks prior to randomization

- Patients must have paraffin-embedded tumor specimen available for central core review
of tumor histology and other correlative studies; tumor samples will be shipped as
specified

- Patients must have no evidence of residual or metastatic renal cell cancer as
documented on computed tomography (CT) scans of the chest, abdomen, and pelvis, all
with oral and intravenous (IV) contrast (magnetic resonance imaging [MRI] scans of
the abdomen and pelvis with gadolinium and a non-contrast CT of the chest may be
substituted if patient is not able to have CT scans with intravenous contrast);
patients unable to tolerate either gadolinium or IV contrast should not participate
in this study (limitations to a patient's renal function should be taken into
consideration when screening for this study)

- Scans must be obtained within 4 weeks of randomization; changes on these scans that
are felt to be post 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
document that there is no evidence of residual disease

- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs
(phenytoin, carbamazepine or phenobarbital), St John's Wort, ketoconazole,
dexamethasone, the dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol,
probucol, bepridil, indapamide or flecainide), haloperidol, risperidone, rifampin,
grapefruit, or grapefruit juice within two weeks of randomization and during the
course of therapy; (medications are not prohibited unless listed above); topical and
inhaled steroids are permitted

- Patients must not receive any other investigational anti-cancer agents during the
period on study

- Patients must not have a serious intercurrent illness, including ongoing or active
infection requiring parental antibiotics

- Absolute granulocyte count (AGC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- 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 x upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) =< 2.5 x ULN

- Patients must be able to swallow pills
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Berkeley, CA
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