We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther) (Panther)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01512186
Recruitment Status : Unknown
Verified June 2014 by Centre of Experimental Medicine, Queen Mary University of London.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : June 12, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate if 14 weeks of pazopanib therapy prior to surgery (nephrectomy) is of benefit to patients with metastatic renal cancer. Ninety-five patients will be recruited into his study.

Condition or disease
Metastatic Clear Cell Renal Cancer

Detailed Description:

This is a Phase II, open label study evaluating pre-operative pazopanib treatment in previously untreated patients with metastatic clear cell renal cancer. This study follows a Simon 2 stage design

Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue after nephrectomy until disease progression is documented. Patients will come off study once disease progression occurs, where they will then be followed for survival. Subsequent treatment at the discretion of the treating physician will be documented.

After surgery, all patients will be radiologically evaluated 8 weekly until progression. Standard radical nephrectomy with lymph node dissection will be performed on those patients who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.

Study Design

Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
Study Start Date : July 2010
Primary Completion Date : February 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria [ Time Frame: Interim analysis after 34 patients have 12 weeks of treatment ]
    12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.

Secondary Outcome Measures :
  1. Surgical complications (blood loss, post operative complications, hospital stay) [ Time Frame: After the first 20 patients have had a nephrectomy ]
    Following surgery information regarding the quantity of blood loss, time the surgery took, length of hospital stay and whether there were any surgical complications will be recorded.

  2. Overall Survival [ Time Frame: After three years of study ]
    Overall survival will be measured from start of treatment to time of death.

  3. Progression free survival [ Time Frame: After all patients have progresssed ]
    Progression free survival will be measured from start of study treatment to time of disease progression.

  4. Local response of primary tumour to pazopanib [ Time Frame: After 12 weeks of study drug ]

Biospecimen Retention:   Samples With DNA
Pre-treatment biopsy and post treatment nephrectomy samples will be obtained

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population for this trial are patients with confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST). Only a component of clear cell is required.

Inclusion Criteria:

  • Histopathologically confirmed clear cell carcinoma with measurable metastases on CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.

    • No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is acceptable to non target lesions.
    • Adequate organ function as defined by the following criteria:

      i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii. Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance >30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor support v. Platelets ≥ 75,000/mm3

    • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
    • Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
    • ECOG performance status of 0, 1 or 2.
    • 18 years or above (no upper age limit) Male or female

Exclusion Criteria:

  • Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or unstable arrhythmia requiring medication.

    • Previous treatment for renal cancer
    • Pregnancy or breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use adequate contraception during the period of therapy.
    • Male patients must be surgically sterile or agree to use adequate contraception during the period of therapy.
    • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would in the judgement of the investigator, impart excess risk associated with study participation or study drug administration, or which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
    • Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs
    • Ongoing major gastrointestinal disease including ulcerative colitis, bleeding peptic ulcer disease or inflammatory bowel disease.
    • Bleeding diathesis
    • Current uncontrolled hypertension
    • Another malignancy requiring treatment within the last 5 years. Local prostate cancer not requiring hormone therapy or an asymptomatic raised PSA is acceptable.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512186

United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Barts and London Hospital NHS Trust
London, United Kingdom
Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
London, United Kingdom
Oncology & Haematology Clinical Trials Unit, Guy's Hospital
London, United Kingdom
Department of Oncology Oxford Cancer Centre
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Southend University Hospital Trust
Southend, United Kingdom
Sponsors and Collaborators
Queen Mary University of London
More Information

Responsible Party: Centre of Experimental Medicine, Thomas Powles, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01512186     History of Changes
Other Study ID Numbers: 2009-016675-29
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014

Keywords provided by Centre of Experimental Medicine, Queen Mary University of London:
Clear cell renal cancer

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