Status:
COMPLETED
A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
CTI BioPharma
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study involves two phases. Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex which can be safely given to subjects when combined with cetuximab and radiother...
Detailed Description
Patients with locally advanced (stage III and IV) head and neck cancer are often managed by radiotherapy with or without chemotherapy because most of them have unresectable tumor, require too extensiv...
Eligibility Criteria
Inclusion
- Patients with histological proof (from the primary lesion and/or cervical lymph node) of squamous carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.
- Patients should have stage III or IV disease
- Patients must have ECOG Performance Status of 0-1
- Patients must be \>/= 18 years of age
- Patients must have measurable disease
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \>/= 1500 cells/mm3, platelet count of \>/= 100,000 cells/ mm3; adequate hepatic function with bilirubin \</= 1.5mg/dl, AST and ALT \</= 2x the upper limit of normal; serum creatinine \</= 1.5mg/dl, creatinine clearance \>/= 50 ml/min and INR 0.8 - 1.2
- Patients must sign a study specific informed consent form prior to study entry
- Final 20 subjects must be HPV negative
Exclusion
- Histology other than squamous cell carcinoma
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations for phase II study subjects
- History of malignancy other than non-melanoma skin cancer
- Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy
- Prior history of allergy or hypersensitivity to cetuximab or paclitaxel
- Weight loss \> 10% in the past three months
- Patients with uncontrolled intercurrent disease
- Patients with currently active malignancy
- Pregnant or lactating women
- Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00660218
Start Date
March 1 2008
End Date
April 1 2017
Last Update
November 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210