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Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

NCT00096174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-06-29

Study results available
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Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.

Conditions

Interventions

BIOLOGICAL

cetuximab C225

400 mg/m\^2 IV over 120 minutes on Day 1, 250 mg/m\^2 IV over 60 minutes on Day 8, then weekly

DRUG

cisplatin

75 mg/m\^2 IV over 30-60 minutes starting day 15 every 3 weeks \* 3 (Days 1, 22, and 43 of radiation therapy (RT))

RADIATION

radiation therapy

RT 70 Gy / 35 starting Day 15, 200cGy / d \* 7 weeks (35 fractions)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Corey J. Langer, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-08
Primary Completion
2009-07-31
Completion
2016-07-31

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Diseases

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 NCT00096174 on ClinicalTrials.gov