NCT02124707

Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN

LCCC 1330 - A Phase II Study of Weekly Carboplatin, Paclitaxel and Cetuximab for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.

Detailed description

Because of their high response rates and low toxicity, the taxane, carboplatin, cetuximab regimens have frequently been adapted for use in the palliative setting. At UNC, we have observed high rates of response, leading to symptomatic benefit and low toxicity. Further, the regimen de-medicalizes the patient's life in several important ways. First, unlike with the EXTREME regimen, no PORT or 4 day infusion is required. Second, the regimen gives only six weeks of cytotoxic therapy. Finally, in our experience there is a low rate of severe toxicity and this, coupled with the high rate of response, may improve quality of life. We are not aware of any presented or published results on the use of this combination in palliative therapy; with the adoption of this regimen in clinical practice, documentation of its benefit via conduct of a clinical trial is needed. We propose a study designed to detect an improvement in median OS versus a historical control. The control arm from the EXTREME trial achieved a median OS of 7.4 months. We hypothesize that a less toxic and more effective 3-drug regimen will result in improved median OS compared with the control arm from EXTREME (median 7.4 months). The toxicity associated with EXTREME is primarily attributable to the cisplatin and 5FU cytotoxic backbone as its toxicity has been consistent in multiple studies of both palliative therapy and induction therapy. If a 4-month improvement in OS is achieved with acceptable toxicity, we will consider this regimen worth of further study. Secondary objectives will include characterizing changes in quality of life (QoL), symptoms and toxicities. Patients will be encouraged to co-enroll into the UNCseq protocol for further exploration of associations between genetic changes and clinical outcomes.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Cetuximab	400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
DRUG	Paclitaxel	135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
DRUG	Carboplatin	AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.

Timeline

• Start date: 2014-06-16
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2014-04-28
• Last updated: 2020-08-12
• Results posted: 2020-08-12

Locations

2 sites across 1 country: United States