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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026337
Other study ID # UPCC 03809
Secondary ID NCI-2009-01414
Status Completed
Phase
First received
Last updated
Start date April 2009
Est. completion date November 2018

Study information

Verified date June 2019
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.

Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.


Description:

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.


Other known NCT identifiers
  • NCT00915993

Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date November 2018
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Genetic:
mutation analysis
Correlative study
Other:
pharmacological study
Correlative study
Procedure:
dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE-MRI
Drug:
sunitinib malate
Given orally
Other:
immunohistochemistry staining method
Correlative study
laboratory biomarker analysis
Correlative study

Locations

Country Name City State
United States Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival
Primary Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)
Secondary Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
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