Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heav… (NCT01758731) | Clinical Trial Compass
CompletedPhase 1
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
United States17 participantsStarted 2012-10-22
Plain-language summary
This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab.
Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a feasible, biologically-based alternative to standard chemoradiation, with acceptable toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking history.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provision of fully informed consent prior to any study specific procedures.
✓. Patients must be \> 18 years of age.
✓. Histologically or cytologically confirmed (from the primary lesion and/or regional lymph nodes) squamous cell carcinoma of the oropharynx, hypopharynx, or larynx that has not been previously treated or resected
✓. Stage IV A or stage IV B disease prior to induction chemotherapy with no proven hematogenous metastatic disease (includes T4aN0-1M0, T1-4aN2M0, T4b, any N, M0 or any T, N3M0)
✓. History of ≥ 10 pack-years of smoking cigarettes.
✓. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix F)
✓. Patients must have a life expectancy ≥ 16 weeks.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
✕. Previous enrollment (or assignment) in the present study
✕. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
What they're measuring
1
Maximum Tolerated Dose (MTD) of Olaparib
Timeframe: 10 weeks from the start of protocol therapy
. Any previous treatment with a PARP inhibitor, including olaparib.
✕. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years.
✕. Patients receiving any systemic chemotherapy or targeted agents for treatment of the current HNSCC
✕. Patients receiving any prior radiation therapy to the head or neck.
✕. Patients receiving the following classes of inhibitors of Cytochrome P450 3A4 (see Section 5.4.2 for guidelines and wash out periods).