MedTrace Logo

Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

NCT00513383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-03-01

No results posted yet for this study

Summary

This study is being done to test whether panitumumab, in combination with chemotherapy and radiation is safe in people with head and neck cancer. Another goal of this study is to find the highest dose of the study drugs that can be given safely without causing serious sife effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in other types of cancers, such as kidney and colon. This monoclonal antibody is directed against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth of head and neck cancer cells.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Panitumumab

Part A: Intravenously once a week for 7 weeks Part B (Induction Chemotherapy): Intravenously on Day 1 of a 21-day cycle for 3 cycles Part B (After Induction chemotherapy): Intravenously once a week for 7 weeks at the dosing level established during Part A

DRUG

Carboplatin

Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks

DRUG

Paclitaxel

Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks

RADIATION

Intensity Modulated Radiation Therapy

Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks

DRUG

5-Fluorouracil

Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles

DRUG

Docetaxel

Intravenously on day 1 of a 21-day cycle for 3 cycles

DRUG

Cisplatin

Intravenously on day 1 of a 21-day cycle for 3 cycles

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lori J. Wirth, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00513383 on ClinicalTrials.gov