A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer

Status: Unknown status
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx

• Measurable or evaluable disease

• No distant metastases

• Tumor should be surgically unresectable for cure or resection is considered inadvisable

• Age > 18 years

• ECOG performance status 0, 1 or 2

• Life expectancy > 2 months

• Patients must have adequate organ and marrow function as defined below:

• Leukocytes > 3,000/mm3

• Absolute neutrophil count > 1,500/mm3

• Platelets > 100,000/mm3

• Hemoglobin > 10.0g/dL

• Total Bilirubin <= institutional upper limit of normal

• Aspartate aminotransferase < 2.5 X institutional upper limit of normal

• Alanine aminotransferase < 2.5 X institutional upper limit of normal

• Alkaline phosphatase < 2.5 X institutional upper limit of normal

• Creatinine <= institutional upper limit of normal OR creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine > institutional upper limit of normal

• Signed informed consent

• Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment

Locations
United States
Vermont
Mountainview Medical Center
Recruiting
Berlin
Fletcher Allen Health Care
Recruiting
Burlington
Vermont Center for Cancer Medicine
Recruiting
Colchester
Contact Information
Primary
Steven M Grunberg, MD
Steven.Grunberg@vtmednet.org
802-847-8400
Backup
Madhuri V Vithala, MD
Madhuri.Vithala@vtmednet.org
802-847-8400
Time Frame
Start Date: September 2009
Completion Date: December 2012
Participants
Target number of participants: 37
Treatments
Experimental: Neoadjuvant/Concomitant Chemoradiation
Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
Sponsors
Leads: University of Vermont

This content was sourced from clinicaltrials.gov

Similar Clinical Trials