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

NCT01512186 | Unknown DMC

• 1 other identifier: 2009-016675-29
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 9

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.

Conditions

Metastatic Clear Cell Renal Cancer

Keywords

Clear cell renal cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria

  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.

  Interim analysis after 34 patients have 12 weeks of treatment

Secondary Outcomes (4)

• Surgical complications (blood loss, post operative complications, hospital stay)

  After the first 20 patients have had a nephrectomy

• Overall Survival

  After three years of study

• Progression free survival

  After all patients have progresssed

• Local response of primary tumour to pazopanib

  After 12 weeks of study drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• years or above (no upper age limit) Male or female

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (9)

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, United Kingdom

Location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Barts and London Hospital NHS Trust

London, United Kingdom

Location

Oncology & Clinical Haematology Trials Unit, Royal Free Hospital

London, United Kingdom

Location

Oncology & Haematology Clinical Trials Unit, Guy's Hospital

London, United Kingdom

Location

Department of Oncology Oxford Cancer Centre

Oxford, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Southend University Hospital Trust

Southend, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Powles

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: January 19, 2012
• Study Start: July 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

GB (9)