Status:
UNKNOWN
Olaparib and Radiotherapy in Head and Neck Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Laryngeal Cancer Stage II
Laryngeal Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Accelerated, normofractionated radiotherapy is the treatment of choice in stage II-III laryngeal and oropharyngeal squamous cell carcinoma (SCC). However, twenty to thirty percent of patients with sta...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Histologically confirmed squamous cell carcinoma of the larynx stage II-III (T2N0M0 or T1-2N1M0 or T3N0-1M0) or histologically confirmed squamous cell carcinoma of the oropharynx stage II-III (T1-2N1M0 or T3N0-1M0)
- In case of oropharyngeal carcinoma: tumor HPV status negative
- WHO performance 0-1
- Life expectancy of at least 6 months
- Adequate hematological, renal and hepatic functions
- Hemoglobin ≥ 6.2 mmol/l
- Leucocytes 3.0 x 10E9/l
- Absolute neutrophil count 1.5x10E9/l
- Platelet count 100 x 10E9/l
- Total bilirubin ≤ 1.5 x UNL
- ASAT/ALAT ≤ 2.5 x UNL
- Creatinine clearance 50 ml/min; measured using a 24-hours urine sample or calculated using the Cockcroft-Gault formula
- Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 21 days of study treatment. Non-childbearing potential or postmenopausal is defined as:
- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- LH and FSH levels in post menopausal range for women under 50 years of age
- Radiation-induced oophorectomy with last menses \> 1 year ago
- Chemotherapy-induced menopause with \> 1 year interval since last menses
- Surgical sterilisation (bilateral oophorectomy or hysterectomy)
- Patients of reproductive potential must agree to practice two effective medically approved contraceptive method during the trial and 3 months afterwards
- Signed written informed consent.
Exclusion
- Patients eligible for concurrent chemoradiotherapy rather than radiotherapy alone
- Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 3 years or more before study entry and the patient has remained disease free)
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea). Patients may continue the use of LHRH agonists for cancer; bisphosphonates for bone disease and corticosteroids.
- Major surgery within two weeks of starting study treatment.
- Participation in other trial with investigational drug or treatment modality
- Gastrointestinal disorders that may interfere with absorption of the study drug or patients who are not able to take oral medication.
- Tube feeding before the start of treatment.
- Prior radiotherapy to head \& neck region.
- Blood transfusion in the four weeks prior to study entry
- Persistent toxicities (CTC ≥ grade 2) with the exception of alopecia, caused by previous cancer therapy
- QT-interval \>470 msec
- Significant cardiovascular disease as defined by:
- History of congestive heart failure defined as NYHA class III
- History of unstable angina pectoris or myocardial infarction up to 3 months prior to trial entry;
- Presence of severe valvular heart disease
- Presence of a ventricular arrhythmia requiring treatment;
- Uncontrolled hypertension
- Patients considered a poor medical risk due to:
- non-malignant systemic disease
- active, uncontrolled infection requiring parenteral antibiotics
- a serious, uncontrolled medical disorder; examples include, but are not limited to:
- uncontrolled major seizure disorder
- unstable spinal cord compression
- superior vena cava syndrome
- extensive bilateral lung disease on HRCT scan
- any psychiatric disorder that prohibits obtaining informed consent.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- Patients with known active hepatic disease (i.e. Hepatitis B or C)
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML on peripheral blood smear.
- Concomitant medications:
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients receiving the following classes of inhibitors of CYP3A4 (see paragraph 6.4.2 for guidelines and wash out periods)
- Azole antifungals
- Macrolide antibiotics
- Protease inhibitors
- Breast-feeding women
Key Trial Info
Start Date :
September 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02229656
Start Date
September 24 2014
End Date
January 1 2024
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX