Clinical trial NCT01566435
Conditions: Head and Neck Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2012-08-09; Completion date: 2019-10-31
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the safety and effectiveness of an induction chemotherapy (ACF) consisting of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), cisplatin and fluorouracil followed by chemoradiation therapy in treating patients with stage III-IV squamous cell cancer of the head and neck. ACF may be an effective way to reduce or downgrade locally aggressive tumors, and improve the chance of eradication by chemoradiation.

Detailed description:
Compared to the standard induction regimen of TPF (docetaxel, cisplatin, and 5-FU), the ACCF (nab-paclitaxel, cisplatin, cetuximab, and 5-FU) regimen included two therapeutic changes: nab-paclitaxel was substituted for docetaxel and cetuximab was added. The investigators propose to eliminate cetuximab from the ACCF regimen to isolate the treatment effects of nab-paclitaxel when given with cisplatin and 5-FU. The primary objective of the ACF proposal is to determine the complete (CR) rate by clinical examination at the primary tumor site following two cycles of ACF. An important secondary objective will be to compare the tumor response rates at the primary site following two cycles of ACF to our historical experience following two cycles of ACCF (protocol # ABX 218/HRPO# 08-0911). In addition, the investigators will compare adverse events (AEs) between patients who receive ACF to the historical group given ACCF. From these two comparisons, we aim to determine if either ACF or ACCF is superior based on a balance of efficacy (using the surrogate prognostic endpoint of CR rate at primary tumor site) and toxicity.

Arms: arm 1: ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)

1. nab-Paclitaxel 100 mg/m\^2 on Days 1, 8, and 15
2. Cisplatin 75 mg/m\^2 on Day 1
3. 5-FU 750 mg/m\^2 on Days 1-3

If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.

Definitive Therapy

1. Cisplatin 100 mg/m\^2 IV on Days 1, 22, and 43
2. Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.
3. If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m\^2 IV week for 8 weeks
Interventions: intervention 1: paclitaxel albumin-stabilized nanoparticle formulation intervention 2: Cisplatin intervention 3: Fluorouracil intervention 4: Intensity modulated radiation therapy intervention 5: Cetuximab intervention 6: Quality-of-life assessment
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12

Protocol documents: