Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of this study is to determine if the addition of proton pump inhibitors (PPIs) to standard chemotherapy can improve progression free survival in patients with head and neck cancer.
Sex
Ages
Volunteers
Inclusion criteria
Males and non-pregnant, non-lactating females at least 18 years old.
Histologically or cytologically confirmed diagnosis of SCCHN (Squamous Cell Carcinoma of the Head and Neck).
Stage IVC (metastatic) or advanced, locally recurrent SCCHN not amenable to curative surgery or radiotherapy.
Measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors) vs 1.1 (Appendix 1).
a. If the only site of measurable disease for this study is within a prior field of irradiation, then the sum of the longest diameters (SLD) of that lesion must have increased by at least 20% from the prior treatment nadir.
ECOG Performance status (measure of health and general well being on a scale of 0 to 5 where 0 represents perfect health) < 1 (Appendix 2).
Expected survival of at least 3 months.
Adequate liver and renal function that is defined as Calculated creatinine clearance of <30ml/min (by Jelliffe calculator) AST (aspartate aminotransferase)/ALT (alanine aminotransferase) < 2.5 X ULN (unless there are hepatic metastasis, in which case AST/ALT within 5 X ULN) Total Bilirubin < 1.5 X ULN (Appendix 5).
Ability to understand and willingness to sign an informed consent form.
Willingness and ability to comply with study procedures and follow up.
There is no restriction on number of prior therapies as long as the patient is deemed a candidate for palliative chemotherapy with one of the standard chemotherapy regimens.
Willingness to use contraception by a method that is deemed effective by the Investigator by both male and female patients of childbearing potential and their partners throughout the treatment period and for at least 30 days following the last cycle of chemotherapy (post menopausal women must have been amenorrheal for at-least 12 months to be considered of non-childbearing potential).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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