This trial is active, not recruiting.

Condition head and neck cancer
Treatments cetuximab, cisplatin, paclitaxel albumin-stabilized nanoparticle formulation, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Phase phase 1/phase 2
Target EGFR
Sponsor University of Texas Southwestern Medical Center
Start date March 2009
End date December 2015
Trial size 80 participants
Trial identifier NCT00851877, ABX 236-HN08US, CDR0000634258, SCCC-112008-019


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Cisplatin, Cetuximab, RT
cetuximab infusion
paclitaxel albumin-stabilized nanoparticle formulation
paclitaxel albumin-stabilized nanoparticle formulation
3-dimensional conformal radiation therapy
3-dimensional conformal radiation therapy
intensity-modulated radiation therapy
intensity-modulated radiation therapy

Primary Outcomes

Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation
time frame: 2 years
disease-free survival
time frame: 2 year

Secondary Outcomes

Dose-limiting toxicities
time frame: 3 month
Safety and tolerability
time frame: 3 month
Progression-free survival
time frame: 5 year
Response rates
time frame: 5 year
Overall survival
time frame: 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

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 < 7 mg/dL or > 12.5 mg/dL - Glucose < 40 mg/dL or > 250 mg/dL - Magnesium < 0.9 mg/dL or > 3 mg/dL - Potassium < 3 mmol/L or > 6 mmol/L - Sodium < 130 mmol/L or > 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)

Additional Information

Official title A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
Principal investigator Hak Choy, MD
Description OBJECTIVES: Primary - To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I) - To evaluate the disease-free survival of patients treated with this regimen. (Phase II) Secondary - To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I) - To assess the safety and tolerability of this regimen. (Phases I and II) - To assess progression-free survival and survival of patients treated with this regimen. (Phase I) - To assess overall survival in patients treated with this regimen. (Phase II) - To assess response rates in patients treated with this regimen. (Phases I and II) OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by a phase II study. Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.