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

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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

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.

Inclusion Criteria:

1. 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.

2. 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.

3. Patients may have received one previous regimen containing traditional immunotherapy
(interferon, interleukin-2), chemotherapy, or combination chemoimmunotherapy for
metastatic disease.

4. Previous nephrectomy is required unless clinically contraindicated (e.g. extensive
liver or bone metastases; primary tumor <5cm).

5. An ECOG performance status of 0 or 1.

6. 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).

7. Absolute neutrophil count (ANC) >1500; platelets >75,000 (within 7 days prior to
study treatment).

8. 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

9. Serum creatinine <2.0 mg/dL.

10. Patients must be able to understand the nature of this study and give written
informed consent.

Exclusion Criteria:

1. Previous treatment with more than one targeted agent, or more than one previous
traditional regimen (e.g., chemotherapy, immunotherapy, chemoimmunotherapy).

2. Previous treatment with sorafenib, temsirolimus, everolimus or other investigational
targeted agents.

3. Inability to swallow and retain oral medication.

4. 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.

5. 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.

6. 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.

7. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel.

8. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal
condition increasing the risk of perforation.

9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 4 weeks prior to beginning therapy.

10. Presence of uncontrolled infection.

11. Concurrent cancer therapy (e.g., chemotherapy, radiation therapy, surgery,
immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).

12. Concurrent treatment with an investigational agent or participation in another
clinical trial.

13. Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever
is longer, preceding the first dose of pazopanib.

14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib.

15. Has taken or is taking prohibited medications.

16. Corrected QT interval (QTc) prolongation defined as QTc interval >470 msec.

17. 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.

18. Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic
peripheral vascular disease.

19. Evidence of bleeding diathesis or coagulopathy.

20. 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

21. 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.

22. Class III or IV heart failure as defined by the New York Heart Association (NYHA)
functional classification system.

23. History of untreated deep venous thrombosis (DVT) within the past 6 months.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

November 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Metastatic
  • Pazopanib
  • Previously-treated
  • Carcinoma
  • Carcinoma, Renal Cell



University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Florida Hospital Cancer Institute Orlando, Florida  32804
Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
Central Maine Medical Center Lewiston, Maine  04240
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Virginia Cancer Institute Richmond, Virginia  23230
Medical Oncology Associates of Augusta Augusta, Georgia  30901
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
St. Louis Cancer Care Chesterfield, Missouri  63017
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
San Francisco Oncology Associates San Francisco, California  94115
Oncology Hematology Care Cincinnati, Ohio  45242
Watson Clinic Center for Cancer Care and Research Lakeland, Florida  33805
Baptist Hospital East Louisville, Kentucky  40207
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Center for Hematology Oncology Boca Raton, Florida  33486