None listed
Conditions
Brief summary
The purpose of this study is to determine if a high dose of an anti-nausea drug (called prochlorperazine) is safe to give to patients during chemotherapy treatment, while also seeing if there is a health outcome benefit to patients. Who is it for? You may be eligible for this study if you are an adult who has a confirmed head and neck cancer or triple negative breast cancer or an adenoid cystic cancer of the head and neck region. Study details All patients in this study will receive a high dose of the anti-nausea medication 3 days after the commencement of chemotherapy. After this, all participants will receive the anti-nausea medication weekly, with their chemotherapy. There will be 5 different doses of the chemotherapy given in combination with the anti-nausea medication to participants depending on when the participant joins the study, with the doses increasing over time and only increasing if the doses pass safety reviews. It is hoped that this research will help determine if the anti-nausea drug is safe in combination with chemotherapy to treat patients, while also testing whether this has an effect on improving health outcomes.
Interventions
Dose escalation of cetuximab by direct administration for 6 weeks (6 doses). Day 1: Initial cetuximab will be administered as per assigned group, group 1) 50mg/mg2, group 2) 100mg/mg2, group 3) 150 mg/mg2, group 4) 250mg/mg2 and group 5) loading dose 400mg/mg2 (day 1) then 250mg/mg2 cetuximab (5 weekly maintenance doses); delivered via intravenous infusion over 2 hours. Cetuximab is to be delivered via an infusion pump and not via a push or bolus delivery. For dose escalation, 5 groups of two p
Dose escalation of cetuximab by direct administration for 6 weeks (6 doses). Day 1: Initial cetuximab will be administered as per assigned group, group 1) 50mg/mg2, group 2) 100mg/mg2, group 3) 150 mg/mg2, group 4) 250mg/mg2 and group 5) loading dose 400mg/mg2 (day 1) then 250mg/mg2 cetuximab (5 weekly maintenance doses); delivered via intravenous infusion over 2 hours. Cetuximab is to be delivered via an infusion pump and not via a push or bolus delivery. For dose escalation, 5 groups of two patients with safety review after each two patients. Day 3: Prochlorperazine will be administered at a dose of 0.8 mg/kg, delivered via intravenous infusion over 20 minutes. Day 8: Cetuximab will be given as per assigned group, dose via intravenous infusion over 1 hour. Prochlorperazine will then be administered at a dose of 0.8mg/kg via intravenous infusion 1 hour after the completion of cetuximab. Cetuximab and prochlorperazine (0.8mg/kg) will be administered on a weekly basis (as per the Day 8 procedures) for a total of five weeks. All patient assessment/monitoring is recorded in the patient clinical record including observations, medication charts and clinical notes.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Radiological and/or histologically confirmed relapsed Head and Neck Squamous Cell Carcinoma/Triple Negative Breast Cancer/Adenoid Cystic Carcinoma of the head and neck region. 2. Predicted life expectancy of greater than three months 3. Male or female greater than or equal to 18 years of age 4. ECOG performance status 0-2 5. Provide informed consent 6. Able to commit to 4 hours in the clinic and 24 hours without driving and operating machinery 7. Female patients of child bearing potential will be required to have a negative pregnancy test prior to entry on the study and be required to practice an effective form of contraception. 8. TNBC patients: histologically confirmed tumour overexpression of EGFR
Exclusion criteria
1. Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer. 2. Known hypersensitivity to EGFR inhibitors. 3. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year before enrolment/randomization. 4. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease previous imaging. 5. Eastern Cooperative Oncology Group (ECOG) performance status greater than 2 6. On drugs that cause long QTc 7. History of prolonged QT interval or prolonged QT interval on baseline ECG 8. Systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 50 mmHg in two consecutive blood pressure readings within the 1 hour prior to study drug administration. 9. Previous reaction to antipsychotic medications 10. Parkinsons disease or other chronic extrapyramidal conditions. 11. Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. 12. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. 13. High risk for poor compliance. 14. Any uncontrolled concurrent medical condition that may interfere with the interpretation of study results.
Outcome results
None listed