Phase 2
N=7
Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00851877 ↗Enrolled (actual)
7
Serious AEs
8.8%
Results posted
Aug 2018
Primary outcome: Primary: Phase I Maximum Tolerated Dose of Nab-Paclitaxel — 20 mg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab (Biological); Cisplatin (Drug); Nab-Paclitaxel (Drug); intensity-modulated radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I Maximum Tolerated Dose of Nab-Paclitaxel |
20 | — |
| PRIMARY Phase II 2-year Progression-free Survival |
60 | — |
| SECONDARY Phase II 2-year Local Control |
71 | — |
| SECONDARY Phase II 2-year Overall Survival |
68 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Diagnosis based on the primary lesion and/or lymph nodes
- Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
- No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
- No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed)
- Bilirubin ≤ 1.5 mg/dL
- AST, ALT, and AP ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
- None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:
- Calcium 12.5 mg/dL
- Glucose 250 mg/dL
- Magnesium 3 mg/dL
- Potassium 6 mmol/L
- Sodium 155 mmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
- No prior allergic reaction to study drugs
- No active cardiac disease, defined as any of the following:
- Unstable angina
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
- Uncontrolled arrhythmia
- Congestive heart failure
- Three or more heart-related hospitalizations within the past year
- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
- No AIDS
- No pre-existing peripheral sensory neuropathy ≥ grade 2
- No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for this cancer
- Prior systemic chemotherapy for a different cancer allowed
- No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
- At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
- No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)
Data sourced from ClinicalTrials.gov (NCT00851877). 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.