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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre of Experimental Medicine, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01512186
First received: October 4, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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
Metastatic Clear Cell Renal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Surgical complications (blood loss, post operative complications, hospital stay) [ Time Frame: After the first 20 patients have had a nephrectomy ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: After three years of study ] [ Designated as safety issue: No ]
    Overall survival will be measured from start of treatment to time of death.

  • Progression free survival [ Time Frame: After all patients have progresssed ] [ Designated as safety issue: No ]
    Progression free survival will be measured from start of study treatment to time of disease progression.

  • Local response of primary tumour to pazopanib [ Time Frame: After 12 weeks of study drug ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Pre-treatment biopsy and post treatment nephrectomy samples will be obtained


Estimated Enrollment: 95
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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: NCT01512186

Locations
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

No publications provided

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
Study First Received: October 4, 2011
Last Updated: June 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Queen Mary University of London:
Clear cell renal cancer

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

ClinicalTrials.gov processed this record on November 20, 2014