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An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma


Primary Objectives:

I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients
treated with sunitinib (PFS).

II. To correlate genetic and histologic characteristics of the primary tumor with vascular
permeability by DCE-MRI.

Secondary Objectives:

I. To correlate genetic and histologic characteristics of the primary tumor with clinical
outcome for patients treated with sunitinib.

II. Samples will be collected for potential future exploratory analyses of pharmacokinetic
and pharmacogenomic parameters.

Outline: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats
every 42 days in the absence of disease progression or unacceptable toxicity.

Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of
sunitinib malate.

Inclusion Criteria


Inclusion

- AJCC stage IV or locally advanced (or inoperable) renal cell carcinoma for which
archival tissue is available

- No prior anti-angiogenic therapy

- Prior radiation therapy to a symptomatic site of disease is allowed

- ECOG performance status of 0, 1 or 2

- White Blood Count >= 3,000/mm^3

- Absolute Granulocyte Count >= 1,500/mm^3

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

- Serum creatinine =< 2.0 x upper limit of normal (ULN) OR serum creatinine clearance
(CrCl) >= 40 ml/min

- Total Bilirubin =< 1.5 x ULN (< 3.0 x ULN in the presence of Gilbert's disease)

- AST/ALT =< 2.5 x ULN (=< 5.0 ULN in the presence of liver metastases)

- INR =< 1.5 and a PTT within normal limits; patients who are taking warfarin must have
documentation of an INR =< 1.5 and a PTT within normal limits prior to the initiation
of anticoagulation to rule out a baseline coagulopathy

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

- 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 ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >=
2

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

- Patients must not have a history or clinical evidence of brain metastasis; however,
patients with resected or radiated brain metastases are eligible

- Patients must not have a serious intercurrent illness including, but not limited to,
ongoing or active infection requiring parenteral antibiotics, 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

- Patients must not have a serious intercurrent illness including, but not limited to,
grade II or greater peripheral vascular disease within 1 year prior to study entry,
or psychiatric illness/social situations that would limit compliance with study
requirements

- Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs
(phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort

- Women must not be pregnant or breast-feeding

- All females of childbearing potential must have a blood test or urine study within 2
weeks prior to registration to rule out pregnancy

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal, barrier method of birth control, or abstinence) prior to study entry and
for the duration of study participation

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Stephen Keefe

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 03809

NCT ID:

NCT01026337

Start Date:

April 2009

Completion Date:

April 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • recurrent renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283