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Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

NCT00627835 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-07-20

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population.

Conditions

  • Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Interventions

DRUG

sorafenib

Cohort 1 - sorafenib 200 mg PO bid concurrent with radiation

DRUG

sorafenib

o Cohort 2 - sorafenib 400 mg PO bid concurrent with radiation

DRUG

sorafenib and cisplatin

Cohort 3 - sorafenib 200 mg PO bid / cisplatin 75 mg/m2 weeks 1, 4 and 7

DRUG

sorafenib and cisplatin

o Cohort 4 - sorafenib 400 mg PO bid/ cisplatin 75 mg/m2 weeks 1, 4 and 7

DRUG

sorafenib and cisplatin

Cohort 5 - sorafenib 400 mg PO bid/ cisplatin 100 mg/m2 weeks 1, 4 and 7

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Stephen Chia, MD · British Columbia Cancer Agency

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Canada

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 NCT00627835 on ClinicalTrials.gov