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Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT00971932 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-04-08

Study results available
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Summary

The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Cetuximab

The initial dose of cetuximab will be 400 milligram per square meter (mg/m\^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m\^2 as an IV infusion over 60 minutes.

DRUG

Cisplatin/Carboplatin

Subjects will receive 100 mg/m\^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 \[AUC5\]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.

DRUG

5-Fluorouracil

Subjects will receive 1000 mg/m\^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Mark P. Smith, MD · Merck Serono Co., Ltd., Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-03-31

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00971932 on ClinicalTrials.gov