drugset / Trial / NCT00030576
Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Phase 1/2
Completed
51 enrolled
University Health Network, Toronto
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.
Timeline
- Start
- 2001-11
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Results Agulnik M, da Cunha Santos G, Hedley D, Nicklee T, Dos Reis PP, Ho J, Pond GR, Chen H, Chen S, Shyr Y, Winquist E, Soulieres D, Chen EX, Squire JA, Marrano P, Kamel-Reid S, Dancey J, Siu LL, Tsao MS. Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib. J Clin Oncol. 2007 Jun 1;25(16):2184-90. doi: 10.1200/JCO.2006.07.6554.
- Results Siu LL, Soulieres D, Chen EX, Pond GR, Chin SF, Francis P, Harvey L, Klein M, Zhang W, Dancey J, Eisenhauer EA, Winquist E; Princess Margaret Hospital Phase II Consortium; National Cancer Institute of Canada Clinical Trials Group Study. Phase I/II trial of erlotinib and cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a Princess Margaret Hospital phase II consortium and National Cancer Institute of Canada Clinical Trials Group Study. J Clin Oncol. 2007 Jun 1;25(16):2178-83. doi: 10.1200/JCO.2006.07.6547.
- Results Winquist E, Soulieres D, Chen E, et al.: A phase II study of erlotinib in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (PHL002es/NCIC CTG IND.157). [Abstract] Eur J Cancer 2 (Suppl 8): A-408, 122, 2004.
- Results Siu LL, Chen X, Tsao M: A phase I/II study of erlotinib (Tarceva) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (HNSCC). [Abstract] Clin Cancer Res 9 (16): A-A92, 2003.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |