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Renal Cell CarcinomaPhase 2NCT00731211

Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

A Phase 2 study testing Pazopanib in people with Renal Cell Carcinoma, run by SCRI Development Innovations, LLC at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic renal cell carcinoma who have received one prior targeted therapy with either sunitinib or bevacizumab. The planned enrollment for this study is 60 patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
17 sitesUnited States
Study dates
Sep 2008to Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma. In patients with mixed histologies, any percentage of clear cell histology is acceptable.
  • Patients must have had only one previous targeted agent therapy with either sunitinib or bevacizumab. Patients must have progressed either during or within 3 months of discontinuing treatment with one of these agents. Patients who stopped either sunitinib or bevacizumab because of unacceptable toxicity are also eligible.
  • Patients may have received one previous regimen containing traditional immunotherapy (interferon, interleukin-2), chemotherapy, or combination chemoimmunotherapy for metastatic disease.
  • Previous nephrectomy is required unless clinically contraindicated (e.g. extensive liver or bone metastases; primary tumor <5cm).
  • An ECOG performance status of 0 or 1.
  • At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques, or as >10 mm with spiral computerized tomography (CT) scan according to the Response Evaluation Criteria in Solid Tumors (RECIST).
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  • Absolute neutrophil count (ANC) >1500; platelets >75,000 (within 7 days prior to study treatment).
  • Adequate liver function as measured by serum bilirubin <1.5 mg/dL and AST/ALT <2.5 times upper limit of normal (ULN) (or <5 x ULN in patients with documented liver metastases).
  • Serum creatinine <2.0 mg/dL.
  • Patients must be able to understand the nature of this study and give written informed consent.

Who cannot join

  • Previous treatment with more than one targeted agent, or more than one previous traditional regimen (e.g., chemotherapy, immunotherapy, chemoimmunotherapy).
  • Previous treatment with sorafenib, temsirolimus, everolimus or other investigational targeted agents.
  • Inability to swallow and retain oral medication.
  • History of other malignancy. Patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Concurrent disease or condition that would make the patient inappropriate for study participation including: (1) any unresolved or unstable serious toxicity from prior administration of another drug, or (2) any serious medical disorder that would interfere with the patient's safety, obtaining informed consent, or compliance with the study.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated parenchymal CNS metastases, are asymptomatic, and have had no requirement for steroids or anticonvulsants for >2 months prior to study enrollment. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated, or if the patient has a history of CNS metastases.
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  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
  • Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
  • Presence of uncontrolled infection.
  • Concurrent cancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
  • Has taken or is taking prohibited medications.
  • Corrected QT interval (QTc) prolongation defined as QTc interval >470 msec.
  • History of any one of the following cardiac conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • History of cerebrovascular accident within the past 6 months
  • Poorly controlled hypertension (systolic blood pressure [SBP] of >140 mmHg, or diastolic blood pressure [DBP] of >90 mmHg).
  • Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re- assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP-DBP values from both BP assessments must be <140/90 mmHg in order for a patient to be eligible for the study.
  • Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study. Minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
  • Pregnant or lactating female. All patients of childbearing potential must agree to use adequate contraception for 2 weeks prior to beginning pazopanib, during the entire study, and for 60 days after pazopanib is discontinued.
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • History of untreated deep venous thrombosis (DVT) within the past 6 months.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Medical Oncology Associates of Augusta

    Augusta, Georgia, 30901

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Watson Clinic Center for Cancer Care and Research

    Lakeland, Florida, 33805

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • San Francisco Oncology Associates

    San Francisco, California, 94115

  • Gulfcoast Oncology Associates

    St. Petersburg, Florida, 33705

Other trials in United States

About this study

Official title: A Phase II Trial of Pazopanib in Patients With Metastatic Renal Cell Carcinoma Previously Treated With Sunitinib or Bevacizumab

This is a Phase II, non-randomized, open-label, single-arm study in patients with metastatic renal cell carcinoma who have received one prior targeted therapy with either sunitinib or bevacizumab. The planned enrollment for this study is 60 patients.

Read the detailed description

All eligible patients will receive 800 mg of pazopanib orally each day continuously. Patients will be re-evaluated for treatment response after 8 weeks of daily oral pazopanib therapy. Response to therapy will be assigned using RECIST criteria (Section 6.0) Patients who have objective response or stable disease will continue treatment with evaluations every 8 weeks, until the time of tumor progression or intolerable treatment-related side effects.

Being tested
Pazopanib
Keywords
Renal Cell Carcinoma, Metastatic, Pazopanib, Previously-treated
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called Votrient

    800 mg of pazopanib orally each day continuously

Study groups in NCT00731211
Study groupRoleWhat they receive
PazopanibExperimental800 mg of pazopanib orally each day continuously
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.

    Measured: 18 months

Secondary outcomes (1)

  1. Progression-free Survival

    Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: every 8 weeks until progressive disease, expected average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2011
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731211
Sponsor's protocol ID
SCRI GU 56
Status last verified
May 2015
First submitted
5 Aug 2008
Last updated
20 May 2015
Data monitoring committee
No

Publications

  • Hainsworth JD, Rubin MS, Arrowsmith ER, Khatcheressian J, Crane EJ, Franco LA. Pazopanib as second-line treatment after sunitinib or bevacizumab in patients with advanced renal cell carcinoma: a Sarah Cannon Oncology Research Consortium Phase II Trial. Clin Genitourin Cancer. 2013 Sep;11(3):270-5. doi: 10.1016/j.clgc.2013.04.006. Epub 2013 May 9.

    PubMed 23665131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib in people with Renal Cell Carcinoma, run by SCRI Development Innovations, LLC at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00731211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.

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