Upstate Active Clinical Trials Seeking Participants
Study title
A Phase I/II Study in Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer.
IRB number
5585
What is the purpose of the study?
1) To determine the maximum tolerated dose of the study drug, paclitaxel poliglumex, when given in combination with radiotherapy and cetuximab for locally advanced head and neck squamous cell carcinoma. (Phase I).
2)To determine the rate of cancer control in the head and neck region at one year following treatment. (PhaseII).
Who is eligible?
1)Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
2) Stage III of IV disease, with no distant metastases.
3) Lab values showing adequate blood counts and liver function
What is involved if I participate?
- How long is the study?
The planned study treatment for each subject will take approximately 8 weeks; each subject will receive standard-of-care post-treatment followup and their progress will be recorded for 5 years. We expect to be able to enroll two subjects per month in this study; therefore, it should take approximately two years to enroll the required 40 subjects for this study. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Pre-Treatment Evaluations: complete medical history and physical exam blood tests CT scan or MRI of the head and neck chest X-ray or CT scan of the chest PET scan - optional bone scan (if clinically indicated) pregnancy test (for women with potential of pregnancy) All of these evaluations are part of standard cancer care.
Who is the doctor administering the study?
Seung Shin Hahn MD.
Where will the study take place?
The radiationtherapy component of this study will take place at either University Hospital or Hill Radiation Oncology. The chemotherapy component of this study will take place at either the Regional Oncology Center (ROC) 1000 East Genesee St, the Oneida Clinic, or the Oswego Clinic.
Over what time period is the study scheduled to run?
October 2007 until accrual of the required 40 subjects is completed.
Who can I contact for more information?
- Name: Dena Martin
- Phone: 315-464-5262
- Email: martind@upstate.edu
- Fax: 315-464-5943
If you are interested in this trial, please contact the study coordinator or investigator noted above.
