Pazopanib/DCE-MRIs in Renal Cell Carcinoma (RCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01221506
First received: October 13, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

All patients who participate in this study will receive pazopanib. Pazopanib is an oral drug (pill) that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer. In this study, the investigators plan to learn more about the way this drug works by using special scans (MRIs and Ultrasounds) to help evaluate how this drug is working on this disease. Approximately 20 people with advanced kidney cancer will be enrolled on this study.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Pazopanib
Device: DCE-MRI and Quantitative Doppler Ultrasound
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Tumor Perfusion Changes in Response to Pazopanib in Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Evaluate Early Changes in DCE-MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To evaluate early changes in DCE-MRI measures of tumor vascular permeability after treatment with pazopanib.


Secondary Outcome Measures:
  • Correlating Baseline DCE-MRI and early changes in DCE-MRI with other measures of treatment effectiveness [ Designated as safety issue: Yes ]
    Correlating baseline DCE-MRI and early changes in DCE-MRI with other measures of treatment effectiveness, including clinical outcomes and histologic measures of tumor angiogenesis.


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pazopanib
    800 mg PO QD x 28 days
    Device: DCE-MRI and Quantitative Doppler Ultrasound
    Contrast-enhanced MRI
Detailed Description:

Overall objectives PRIMARY: - Assessment of early changes in DCE-MRI and ultrasound measures of tumor perfusion in the setting of pazopanib therapy for patients with metastatic clear cell renal cell carcinoma SECONDARY: - Correlation of baseline DCE-MRI and ultrasound parameters and clinical outcome - Correlation of early (48 +/- 24 hr after treatment) changes in DCE-MRI and ultrasound parameters and clinical outcome - Correlation of baseline (and changes) in DCE-MRI and ultrasound parameters with VHL status in tumors and histocytometric analysis of endothelial cell activation in archival nephrectomy specimens - Provide an insight in the respective predictive values of DCE-MRI and US for pazopanib treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of unresectable and/or metastatic clear cell renal cell carcinoma. 10 patients will be enrolled who have had no prior anti-angiogenic therapy; 10 patients will be enrolled who have had one prior anti-angiogenic therapy
  • Prior radiation therapy to a symptomatic site of metastatic disease is allowed but patients must have discontinued/completed radiation therapy at least 2 weeks prior to entering the study, and have recovered from adverse events due to that treatment.
  • ECOG performance status of 0, 1 or 2.
  • Patients must have measureable disease by RECIST 1.1
  • Archived tumor blocks must be provided for all subjects for correlative analysis before or during treatment with pazopanib
  • Patient must have normal baseline laboratory values
  • Patients must not receive any other investigational agents while onstudy.
  • Patients must not be taking cytochrome P450 enzyme -inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St.Johns wort.
  • Females of childbearing potential are eligible to enter and participate in this study if they have a negative pregnancy test and agree to use medically accepted contraception throughout the study

Exclusion Criteria:

  • Female subjects who are pregnant or brestfeeding - Patients with active prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
  • Patients with a history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Patients with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
  • Patients with clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • Patients the presence of uncontrolled infection.
  • Patient with corrected QT interval (QTc) greater than 480 msecs using Bazetts formula
  • Patients with a history of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; Coronary artery bypass graft surgery; Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) [See Section YYY Appendix Y for description
  • Patient with poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater or equal to 140 mmHg or diastolic blood pressure (DBP) of greater or equal to 90mmHg].
  • Patients with a history of cerebrovascular accident including transient ischemic attack (TIA),pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Patients who have had prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
  • Patients who have evidence of active bleeding or bleeding diathesis.
  • Patients with known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
  • Patients with hemoptysis within 6 weeks of first dose of study drug.
  • Patients with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.
  • Patients who are unable or unwilling to discontinue use of prohibited medications list in Section4.3 for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
  • Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib; OR chemotherapy,immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of pazopanib. Treatment with prior sorafenib, sunitinib, temsirolimus or everolimus is allowed but must be discontinued at least 5 days prior to beginning pazopanib.
  • Patient who have any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1 and/or that is progressing in severity, except alopecia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221506

Contacts
Contact: Naomi Haas, MD 215-349-8913 Lauren.Mennine@uphs.upenn.edu

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Naomi Haas, MD    215-349-8913    Lauren.Mennine@uphs.upenn.edu   
Principal Investigator: Naomi Haas, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Naomi Haas, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01221506     History of Changes
Other Study ID Numbers: UPCC 34809
Study First Received: October 13, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
unresectable
metastatic
clear cell renal carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014