Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Biological: CetuximabRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT00851877
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description arm one Cetuximab Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy arm one intensity-modulated radiation therapy Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy arm one Nab-Paclitaxel Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy arm one Cisplatin Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy
- Primary Outcome Measures
Name Time Method Phase I Maximum Tolerated Dose of Nab-Paclitaxel 90 days Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.
Phase II 2-year Progression-free Survival 2 year Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.
- Secondary Outcome Measures
Name Time Method Phase II 2-year Local Control 2 year Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions
Phase II 2-year Overall Survival 2 year median follow-up 24 months for 34 patients
Trial Locations
- Locations (2)
Baylor Research Institute
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States