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)

European Organisation for Research and Treatment of Cancer (EORTC)0 sites220 target enrollmentStarted: April 3, 2014Last updated: May 13, 2024

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor
Enrollment: 220

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

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
•- 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

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
•- 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.

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer (EORTC)

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