drugset / Trial / NCT00425386
Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.
Timeline
- Start
- 2006-08
- Primary completion
- 2010-08
- Completion
- 2014-03
Outcome
Missed primary endpoint
paper The 8-month PFS rate was 40% (95% CI: 23-56). PMID 35688679 ↗
paper While sunitinib and erlotinib are combinable,the 8-month PFS rate did not suggest efficacy improvement over sunitinib monotherapy (NCT00425386). PMID 35688679 ↗
Publications
- Results Ryan CW, Curti BD, Pattee KJ, et al.: A dose-escalation phase II study of sunitinib (S) plus erlotinib (E) in advanced renal carcinoma (RCC). [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-361, 2008.
- Feng Z, Curti BD, Quinn DI, Strother JM, Chen Z, Agnor R, Beer TM, Ryan CW. A Phase II, Single-arm Trial of Sunitinib and Erlotinib in Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2022 Oct;20(5):415-422. doi: 10.1016/j.clgc.2022.04.018. Epub 2022 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 50 mg | — |
| Subject | Erlotinib | Small molecule | 75 mg | — |
| Subject | Erlotinib | Small molecule | 100 mg | — |
| Subject | Erlotinib | Small molecule | 125 mg | — |
| Subject | Erlotinib | Small molecule | 150 mg | — |
| Subject | Sunitinib | Small molecule | 50 mg | Oral |