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Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer

NCT00736944 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-09

Study results available
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Summary

This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Abraxane

100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3

DRUG

Cetuximab

400 mg/m2 IVPB, Day 1, cycle 1

DRUG

Cetuximab

250 mg IVPB, Day 8 and 15 cycle 1, Day 1, 8 and 15 of cycles 2 and 3

DRUG

Cisplatin

75 mg/m2 IVPB Day 1, cycles 1, 2 and 3

DRUG

5-FU

750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3

RADIATION

Radiation (Post induction)

Monday-Friday, weeks 1-7

DRUG

Cisplatin

(Post induction) Cisplatin 100 mg/m2 IVPB on radiation day 1, 22 and 42

DRUG

Cetuximab

(Post-induction) Cetuximab (for patients who cannot receive cisplatin) will begin (+/- 3 days) before starting radiation therapy at 400 mg/m2 IVPB. Subsequent doses of cetuximab will be given weekly at 250 mg/m2 IVPB

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Douglas Adkins, M.D. · Washington Univerisity

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-19
Primary Completion
2010-08-31
Completion
2020-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT00736944 on ClinicalTrials.gov