Phase 2
N=30
Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT00736944 ↗Enrolled (actual)
30
Serious AEs
63.3%
Results posted
Jan 2014
Primary outcome: Primary: Clinical Complete Response Rate at the Primary Tumor — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abraxane (Drug); Cetuximab (Drug); Cisplatin (Drug); 5-FU (Drug); Radiation (Post induction) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Complete Response Rate at the Primary Tumor |
16 | — |
| SECONDARY Clinical Partial Response Rate at the Primary Tumor |
14 | — |
| SECONDARY Clinical Complete and Partial Response Rates to the Involved Regional Nodes |
11; 7 | — |
| SECONDARY Clinical Overall Complete and Partial Response Rates |
13; 17 | — |
| SECONDARY Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan |
9; 17 | — |
| SECONDARY Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan |
9; 14 | — |
| SECONDARY Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria |
10; 11 | — |
| SECONDARY Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria |
7; 12 | — |
| SECONDARY Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria |
4; 14 | — |
| SECONDARY Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT |
53; 33; 32; 47; 41; 61 | — |
| SECONDARY Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT |
61; 30; 36; 39; 48; 56 | — |
| SECONDARY Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT |
43; 14; 24; 57; 50; 66 | — |
| SECONDARY Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy |
14; 0; 1; 0; 0 | — |
| SECONDARY Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy |
6; 4; 1; 2; 0 | — |
| SECONDARY Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy |
14; 0; 1; 0 | — |
| SECONDARY Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy |
6; 2; 4; 1 | — |
| SECONDARY Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis |
1; 1; 1; 1; 1; 10 | — |
| SECONDARY Overall Survival |
83.960 | — |
| SECONDARY Disease Free Survival |
93.529 | — |
| SECONDARY Time to Progression |
38.675 | — |
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 cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Eligibility Criteria
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 /= 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.
Data sourced from ClinicalTrials.gov (NCT00736944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.