Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00851877|
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: Cetuximab Drug: Cisplatin Drug: Nab-Paclitaxel Radiation: intensity-modulated radiation therapy||Phase 1 Phase 2|
- 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)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 1, 2009|
|Actual Primary Completion Date :||October 1, 2013|
|Actual Study Completion Date :||August 3, 2015|
Experimental: arm one
Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor
Cisplatin is an anti-cancer chemotherapy drug
Other Name: Platinol
paclitaxel albumin-stabilized nanoparticle formulation
Other Name: Abraxane
Radiation: intensity-modulated radiation therapy
intensity-modulated radiation therapy
- Phase I Maximum Tolerated Dose of Nab-Paclitaxel [ Time Frame: 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 [ Time Frame: 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.
- Phase II 2-year Local Control [ Time Frame: 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 [ Time Frame: 2 year ]median follow-up 24 months for 34 patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851877
|United States, Texas|
|Baylor Research Institute|
|Dallas, Texas, United States, 75204|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75239|
|Principal Investigator:||Hak Choy, MD||Simmons Cancer Center|