TerminatedPhase 2

Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer

Stopped: Principle Investigator left the institution.

United States7 participantsStarted 2010-06

Plain-language summary

This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult patients 18 years and older with histologically proven locally advanced stage III or IV unresectable Squamous cell head and neck cancer SCCHN (including cancers of oral cavity, oropharynx, larynx and hypopharynx) with no evidence of distant metastasis
✓. A careful evaluation for resection is required from the surgeon and criteria for unresectability carefully defined for individual primary sites as follows:
✓. Patients must have received no prior treatment for head and neck cancer
✓. ECOG Performance status 0-1
✓. Adequate organ function (All labs should be obtained within 14 days prior to start of study drug treatment)
✓. Ability to give informed consent and willingness to adhere to study protocol
✓. Subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study

Exclusion criteria

What they're measuring

Complete Response

Timeframe: Analysis at Week 26

Trial details

NCT IDNCT01326923

SponsorLouisiana State University Health Sciences Center Shreveport

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2020-07-23

View on ClinicalTrials.gov More Head and Neck Squamous Cell Cancer trials