Salivary gland cancer MedDRA version: 20.0 Level: PT Classification code 10061934 Term: Salivary gland cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Bicalutamide
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BICALUTAMIDE
CAS Number: 90357-06-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
European Organisation for Research and Treatment of Cancer (EORTC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for patients at registration: ? Histologically proven diagnosis of recurrent and/or metastatic salivary duct cancer; adenocarcinoma NOS; and AR expression level of = 6 in nuclei of neoplastic cells based on central review (please refer to AR testing guidelines for more details) Sufficient tissue must be available either from a historical sample or a new biopsy must be done as a part of this study and sent for central review for patients to be enrolled in both cohorts; ? Presence of at least one uni-dimensional measurable lesion by CTscan or MRI according to RECIST criteria version 1.1 (target lesion). A lesion previously treated with radiotherapy can be chosen as a target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy; ? No actively bleeding tumor if the patient is intended to be treated with carboplatin ? Patients 18 years old or older; ? Performance Status ECOG 0-1; ? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; ? Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Treatment naïve and pretreated patients will be enrolled in two distinct Cohorts during enrollment, Cohort A and Cohort B, respectively. The following selection criteria are valid for both Cohorts A and B: ? Central pathology confirmation of AR expression ? Adequate bone marrow function (within 2 weeks prior to treatment start): - WBC = 3.5/109L - absolute neutrophil count = 1,5x109/L - hemoglobin > 10 g/dL or > 6.20 mmol/L - platelet count = 100x109/L ? Adequate liver function (within 2 weeks prior to treatment start): - AST < 2.5 times upper limit of normal - ALT < 2.5 times upper limit of normal - bilirubin < 1.5 times upper limit of normal ? Adequate renal function (within 2 weeks prior to treatment start): - serum creatinine level (= 1.3 mg/dL) - calculated creatinine clearance = 60 mL/min based on the standard Cockcroft and Gault formula ? Adequate cardiac function as demonstrated by a clinically normal 12 lead ECG (triplicate method) and normal left ventricular ejection fraction (LVEF) = 50% (within 2 weeks prior to treatment start) either by echocardiography or multi-gated radionuclide angiography (MUGA) as per national guidelines. ? Absence of any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia and vitiligo ? Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to the first dose of study treatment and prior to the start of every cycle. ? Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator and the Clinical Trials Facilitation Group (CTFG) guidelines, during the study treatment period based on national guidelines and clinical judgment of participating investigator and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly; women should not breastfeed a baby while on this study - The highly effective methods of contraception include total sexual abs
Exclusion criteria
Exclusion criteria: Exclusion Criteria for all patients at registration ? Pregnant or lactating women ? Actively bleeding tumor if the patient is intended to be treated with carboplatin ? Cardiac abnormalities as demonstrated by - recent history of congestive heart failure - unstable angina within the past 3 months - cardiac arrhythmia - myocardial infarction - history of prolonged QT interval or intake of medications that have risk for QT prolongation - stroke - TIA within the past 6 months; ? Previous cardiac toxicity induced by another anthracycline or previous exposure to maximum cumulative dose of another anthracycline if the patient is intended to be treated with doxorubicin ? History of allergic reactions attributed to compounds of similar chemical or biological composition to cis/carboplatin, paclitaxel, doxorubicin, bicalutamide or triptorelin ? Concomitant medications with terfenadine, astemizole, cisaprid ? Use of phenytoin ? Active second malignancy during the last five years except nonmelanoma skin cancer or carcinoma in situ of the cervix; ? Patients with bone disease or brain disease as the sole disease site are excluded; brain metastases are allowed in the case of systemic disease, but must have been treated at least 4 weeks before enrollment and must be stable thereafter; ? Patients who received vaccine for yellow fever are not eligible ? Patients with an immediate family member (e.g. spouse, parent/legal guardian, sibling or child) who is in investigational site or Sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The two main objectives of the study are: ? To assess the efficacy of androgen deprivation therapy in treatment naïve patients with recurrent and/or metastatic, androgen receptor expressing, salivary gland cancers (SGCs). The primary measure of efficacy is Progression-Free Survival. ? To describe the effect of androgen deprivation therapy in pretreated patients with recurrent and/or metastatic, androgen receptor expressing SGCs. The main measure of efficacy is response to treatment.;Secondary Objective: Not applicable;Primary end point(s): Cohort A (treatment naïve patients): Progression-Free Survival according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 and/or Prostate Cancer Clinical Trials Working Group (PCWG2) (2007) for bone lesions, or death, whichever comes first. Cohort B (pretreated patients): Best Overall Response defined according to RECIST v 1.1.;Timepoint(s) of evaluation of this end point: During treatment RECIST criteria evaluation will be performed at week 8, 16 and 28 and every 12 weeks thereafter (+/- 1 week) through head and neck and thorax CT scan or head and neck MRI. PCWG2 evaluation will be performed at the same time-points through bone scans. After the end of treatment and up to disease progression imaging will be done every 12 weeks and other investigations should be done if clinically indicated or based on institutional standard practice. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For treatment-naïve patients: - Best Overall Response defined according to RECIST v 1.1 - Overall Survival - Toxicity For pre-treated patients: - Progression Free Survival - Overall Survival - Toxicity;Timepoint(s) of evaluation of this end point: The time-points for evaluation of Best Overall Response and Progression Free Survival are the same as for the primary endpoint; at week 8, 16 and 28 and every 12 weeks thereafter (+/- 1 week). In addition overall survival will be assessed through long-term follow-up once every year. Toxicity will be assessed prior to each treatment cycle and at the end of treatment. | — |
Countries
Austria, Belgium, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, United Kingdom
Contacts
Public ContactRegulatory Affairs Dept
European Organisation for Research and Treatment of Cancer (EORTC)
Outcome results
None listed