Status:
UNKNOWN
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
Lead Sponsor:
University of Vermont
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Chemoradiotherapy has become the standard of care for patients with unresectable head and neck cancer, but there can be substantial added toxicity with chemoradiotherapy compared to radiation therapy ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Previous chemotherapy for this malignancy
- Previous radiotherapy to head and neck region
- Other malignancy within last 5 years except for non-melanoma skin cancer
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Peripheral neuropathy \> Grade 2
- Hypercalcemia
- Patient is pregnant or lactating
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00982436
Start Date
September 1 2009
End Date
December 1 2012
Last Update
March 22 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Mountainview Medical Center
Berlin Corners, Vermont, United States, 05602
2
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
3
Vermont Center for Cancer Medicine
Colchester, Vermont, United States, 05446