A Phase II Study Investigating Upfront Pazopanib In Metastatic Renal Cancer Renal Cancer (Panther) (Panther)
A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
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Basildon、イギリス
- Basildon and Thurrock University Hospitals NHS Foundation Trust
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Coventry、イギリス
- University Hospitals Coventry & Warwickshire NHS Trust
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Glasgow、イギリス
- The Beatson West of Scotland Cancer Centre
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London、イギリス
- Barts and London Hospital NHS Trust
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London、イギリス
- Oncology & Clinical Haematology Trials Unit, Royal Free Hospital
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London、イギリス
- Oncology & Haematology Clinical Trials Unit, Guy's Hospital
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Oxford、イギリス
- Department of Oncology Oxford Cancer Centre
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Southampton、イギリス
- Southampton General Hospital
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Southend、イギリス
- Southend University Hospital Trust
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria
時間枠:Interim analysis after 34 patients have 12 weeks of treatment
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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.
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Interim analysis after 34 patients have 12 weeks of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Surgical complications (blood loss, post operative complications, hospital stay)
時間枠:After the first 20 patients have had a nephrectomy
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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.
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After the first 20 patients have had a nephrectomy
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Overall Survival
時間枠:After three years of study
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Overall survival will be measured from start of treatment to time of death.
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After three years of study
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Progression free survival
時間枠:After all patients have progresssed
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Progression free survival will be measured from start of study treatment to time of disease progression.
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After all patients have progresssed
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Local response of primary tumour to pazopanib
時間枠:After 12 weeks of study drug
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After 12 weeks of study drug
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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