Status:
COMPLETED
Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Celgene Corporation
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with...
Detailed Description
Primary objective: To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients ...
Eligibility Criteria
Inclusion
- Inclusion
- Selected Stages 3 and 4a/b HNSCC: All patients must have T2-T4 primary tumors. Patients with T1 tumors will be excluded. Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible.
- Oropharynx, hypopharynx, larynx, and oral cavity sub-sites only. Patients with nasopharyngeal, sinus and other sub-sites of the head and neck, or unknown primary SCC of the head and neck will NOT be eligible.
- Age ≥18 years
- Signed informed consent.
- ECOG Performance Status (PS) of 0-2 (Appendix 1).
- Adequate vital organ function (serum creatinine \< 1.8 mg/dl, total bilirubin \</= 1.5 mg/dl, ALT and AST \</= 2.5 x ULN, alkaline phosphatase \</= 2.5 x ULN) and hematopoietic function (ANC \>/= 1500/ul, Platelets \> 100,000/ul, HGB \> 9.0 g/dl).
- Patients with reproductive potential must use an effective method of contraception to avoid pregnancy for the duration of the trial and for three months after completing treatment.
- If female of childbearing potential, the patient must have a negative pregnancy test.
- Exclusion Criteria:
- Peripheral neuropathy \> Grade 1.
- Prior chemotherapy, EGFR targeted therapy or radiation therapy for HNSCC.
- History of prior invasive malignancy diagnosed within the last three years other than local stage non-melanoma skin cancer.
- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication for one week before receiving treatment with Abraxane.
- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication for one week before receiving treatment with Abraxane.
Exclusion
Key Trial Info
Start Date :
December 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00736944
Start Date
December 19 2008
End Date
July 6 2020
Last Update
September 9 2020
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110