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Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer

NCT00405405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-05-06

No results posted yet for this study

Summary

To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer

Conditions

Interventions

DRUG

Cisplatin

* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy

DRUG

Docetaxel

* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy

DRUG

Bevacizumab

* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy

DRUG

Erlotinib

* Two cycles during neoadjuvant therapy (dose escalation) * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy

RADIATION

Radiotherapy

Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Pramila Rani Anne, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00405405 on ClinicalTrials.gov