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

Metastatic Clear Cell Renal Cancer Clinical Trial

— Panther  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01512186
• Other study ID #: 2009-016675-29
• Status: Active, not recruiting
• Phase: N/A
• First received: October 4, 2011
• Last updated: June 11, 2014
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Clear Cell Renal Cancer

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Surgical complications (blood loss, post operative complications, hospital stay)	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.	After the first 20 patients have had a nephrectomy	No
Secondary	Overall Survival	Overall survival will be measured from start of treatment to time of death.	After three years of study	No
Secondary	Progression free survival	Progression free survival will be measured from start of study treatment to time of disease progression.	After all patients have progresssed	No
Secondary	Local response of primary tumour to pazopanib		After 12 weeks of study drug	No