Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 22, 2012

Primary Completion Date

December 5, 2016

Study Completion Date

October 31, 2018

Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Olaparib

Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.

DRUG

Cetuximab

Pre-RT cetuximab (C225), 400 mg/m²IV and weekly C225, 250 mg/m2 IV in during RT.

RADIATION

Radiation Therapy

RT to a total dose of 69.3 Gy (primary tumor and involved lymph nodes) in 33 fractions over 6 and 1/2 weeks

Trial Locations (1)

80045

University of Colorado Denver, Denver

All Listed Sponsors
lead

University of Colorado, Denver

OTHER

NCT01758731 - Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History | Biotech Hunter | Biotech Hunter