Metastatic Clear Cell Renal Cancer Clinical Trial
Official title:
A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01714765 -
Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer
|
Phase 1 |