NCT00570674

Abraxane in Combination With Carboplatin, Erbitux and IMRT for Locally Advanced Squamous Cancer of the Head and Neck

A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Phase I part of this research study is to determine the safest and most effective dose of Abraxane when given in combination with carboplatin and Erbitux during radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is to determine the effects of the treatment on head and neck cancers, as well as to further study the safety of this treatment.

Detailed description

Primary Objectives 1. Phase I-To identify the maximally tolerated dose (MTD) of Abraxane given with carboplatin plus concurrent IMRT (AC-RT) 2. Phase II-To evaluate efficacy in the phase II portion of the study by evaluating 2-year disease-free survival Secondary Objectives 1. To evaluate the safety and tolerability 2. To estimate the overall response rate 3. To estimate 2-year overall survival 4. To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life (QoL), by determining mean duration of PEG-dependence and change in FACT-HN scores from baseline to 3, 6, 12 and 24 months. STATISTICAL DESIGN: The Phase I study followed a standard 3+3 dose escalation design. Four potential dose levels of Abraxane ultimately were under evaluation including a de-escalation dose level -1. \[Note: Erbitux was originally planned to be given with carboplatin and Abraxane, but removed due to toxicity experienced at dose level 1.\] The DLT observation period is the 7 weeks of treatment. The Phase I incorporated a10-patient expansion cohort to ensure that the toxicity at the MTD for AC-RT was acceptable. Planned enrollment for the Phase II study was 34 patients primarily to test whether 2-year disease-free survival was consistent with 75% rate as opposed to the null hypothesis of 53.5% based on prior research (RTOG 99-14).

Conditions

• Squamous Cell Carcinoma of the Head and Neck
• Basaloid Squamous Cell Carcinoma
• Undifferentiated Carcinoma
• Adenosquamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Abraxane
DRUG	Erbitux
DRUG	Carboplatin
RADIATION	Intensity Modulated Radiation Therapy

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2007-12-11
• Last updated: 2017-11-13
• Results posted: 2016-12-12