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A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer

NCT00660218 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-11-08

No results posted yet for this study

Summary

This study involves two phases. Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex which can be safely given to subjects when combined with cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel poliglumex is found, Phase II of the study will continue to find out whether the addition of paclitaxel poliglumex increases tumor response and survival compared to treatment with cetuximab and radiotherapy alone.

An additional 20 patients have been added, to balance data. These patients must be HPV negative.

Conditions

  • Carcinoma, Squamous Cell

Interventions

DRUG

paclitaxel poliglumex

Phase I: 40 mg/m2 IV weekly in Cohort 1 (first 3 subjects), escalating in increments of 10 mg/m2 for Cohorts 2 through 5 (3 subjects each) until the maximum tolerated dose (up to 80 mg/m2 IV weekly) is established; Phase II: MTD mg/m2 IV weekly as established in Phase I (24 additional subjects)

BIOLOGICAL

cetuximab

400 mg/m2 IV loading dose one week prior to starting other study treatments, then 250 mg/m2 IV weekly on same day as paclitaxel poliglumex

RADIATION

radiation therapy (IMRT or 3D-CRT)

radiation therapy to the head and neck, consisting of 33 daily fractions of 2.12 Gy for a total of 69.96 Gy, to begin the same day as paclitaxel poliglumex

Sponsors & Collaborators

  • CTI BioPharma

    collaborator INDUSTRY

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Seung Shin Hahn, MD · State University of New York - Upstate Medical 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
2008-03-31
Primary Completion
2016-12-31
Completion
2017-04-30

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 NCT00660218 on ClinicalTrials.gov