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Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

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ClinicalTrials.gov Identifier: NCT01969578
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date July 31, 2020
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Progression Free Survival (PFS) [ Time Frame: 37 months after First Patient In ]
    PFS is a primary outcome for cohort A
  • Response rate (RR) [ Time Frame: 37 months after First Patient In ]
    RR is a primary outcome for cohort B
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Response Rate (RR) [ Time Frame: 37 months after First Patient In ]
    RR is a secondary outcome for cohort A
  • Progression Free Survival (PFS) [ Time Frame: 37 months after First Patient In ]
    PFS is a secondary outcome for cohort B
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 21, 2013)
  • Overall Survival (OS) [ Time Frame: 37 months after First Patient In ]
  • Adverse Events according to CTCAE v4.0 [ Time Frame: 37 months after First Patient In ]
    adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Androgen Deprivation Therapy in Advanced Salivary Gland Cancer
Official Title  ICMJE 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)
Brief Summary

Salivary Gland (SG) Cancers are a rare and heterogeneous group of tumors, usually approached by multidisciplinary teams in high specialized centers. Until today no standard of care exists to treat these cancers. The identification of a target, the androgen receptor, in SG tumors has allowed for new treatment strategies options for this rare group of diseases. As a matter of fact, strong positivity for androgen expression has been found in salivary duct carcinoma and adenocarcinomas. The purpose of this study is therefore to evaluate the efficacy and safety of chemotherapy versus androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic AR expressing SGCs.

The study will include two cohorts of patients: Cohort A, which comprises chemo-naïve patients, and Cohort B, which comprises pretreated patients.

Detailed Description Patients in Cohort A will be randomized 1:1 at the study entry to receive ADT (triptorelin + bicalutamide 50 mg) or standard chemotherapy. Patients of Cohort A randomized to the control arm (chemotherapy arm) will be given the option to enter Cohort B at the time of disease progression. As long as Cohort A is open to recruitment, patients who will be treated by chemotherapy will be simultaneously enrolled in Cohort B. Accrual in Cohort B will be stopped when recruitment of 76 eligible patients in Cohort A is reached.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Salivary Gland Cancer
Intervention  ICMJE
  • Drug: bicalutamide + triptorelin
  • Drug: Cisplatin + Doxorubicin
  • Drug: Carboplatin + Paclitaxel
Study Arms  ICMJE
  • Active Comparator: Chemotherapy

    Chemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel

    Patients from cohort A (chemonaïve) may be randomized in this arm to receive chemotherapy

    Interventions:
    • Drug: Cisplatin + Doxorubicin
    • Drug: Carboplatin + Paclitaxel
  • Experimental: Androgen Deprivation Therapy (ADT)

    ADT = bicalutamide + triptorelin

    Patients from cohort A (chemonaive) may be randomized to receive ADT, and patients from cohort B (pre-treated) will receive ADT without having been randomized.

    Intervention: Drug: bicalutamide + triptorelin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven diagnosis of recurrent and/or metastatic salivary duct cancer; adenocarcinoma, NOS; and AR expression in at least 70% of nuclei of neoplastic cells based on central review
  • Sufficient tissue must be available either historically or a biopsy must be done as a part of this study and sent to central review for patients enrolled in both cohorts
  • Presence of at least one uni-dimensional measurable lesion by CT-scan or MRI according to RECIST criteria version 1.1 (target lesion).
  • Patients older than 18 years old;
  • Performance Status ECOG 0-1;
  • Adequate bone marrow function:
  • WBC ≥ 3.5/10exp9L
  • absolute neutrophil count ≥ 1,5x10exp9/L
  • hemoglobin > 9 g/dL
  • platelet count ≥ 100x10exp9/L
  • Adequate liver function:
  • AST < 2.5 times upper limit of normal
  • ALT < 2.5 times upper limit of normal
  • bilirubin < 1.5 times upper limit of normal
  • the concomitant evidence of AST < 2.5 times upper limit of normal, ALT < 2.5 times upper limit of normal and bilirubin > 1.5 times upper limit of normal is not allowed
  • Adequate renal function:
  • 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; additionally for patients who will receive Cisplatin and Doxorubicin adequate cardiac function should be demonstrated by a left ventricular ejection fraction (LVEF) ≥ 50% (within 2 weeks prior to treatment start)

Exclusion Criteria:

  • Actively bleeding tumor if the patient is intended to be treated with carboplatin
  • Patients with bone disease or brain disease as the sole disease site; brain metastases are allowed in case of systemic disease, but must have been treated at least 4 weeks before enrollment and must be stable after that;
  • recent history of congestive heart failure, unstable angina within the past 3 months, cardiac arrhythmia, myocardial infarction, congenital long QTc 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
  • Patients who received vaccine for yellow fever
  • active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix;
  • positive serum pregnancy test within 1 week prior to the first dose of study treatment for Women of child bearing potential (WOCBP);
  • no adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last study treatment for patients of childbearing / reproductive potential.
  • psychological, familiar, 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;
  • written informed consent not given according to ICH/GCP, and national/local regulations, before patient registration
  • participation in another interventional clinical trial in the preceding 4 weeks prior to randomization
  • for cohort A patients: previous chemotherapy for recurrent/metastatic disease (previous chemotherapy given concomitantly with RT in the past is allowed, including cisplatin but it should be completed at least 6 months before enrollment).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: EORTC HQ +32 2 774 1611 eortc@eortc.org
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969578
Other Study ID Numbers  ICMJE EORTC-1206
2013-000314-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Licitra Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
Study Chair: Kevin Harrington The Royal Marsden
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP