A randomized phase II study to evaluate the efficacy and safety of chemotherapy (CT) vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor (AR) expressing, salivary gland cancer (SGCs)
- Conditions
- Salivary gland cancerMedDRA version: 20.0Level: PTClassification code 10061934Term: Salivary gland cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000314-38-NL
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
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 ARtesting 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
abstinence, combine (estrogen and progestogen
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method