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Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by European Organisation for Research and Treatment of Cancer - EORTC
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT01969578
First received: September 24, 2013
Last updated: August 11, 2017
Last verified: August 2017
  Purpose

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.


Condition Intervention Phase
Salivary Gland Cancer Drug: bicalutamide + triptorelin Drug: Cisplatin + Doxorubicin Drug: Carboplatin + Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 152
Study Start Date: February 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy

Chemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel

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

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.

Drug: bicalutamide + triptorelin

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969578

Contacts
Contact: Dominiek Staelens, PhD dominiek.staelens@eortc.be
Contact: General study e-mail address 1206@eortc.be

Locations
Austria
Medical University Vienna - General Hospital AKH Recruiting
Vienna, Austria, 1090
Principal Investigator: Thorsten Fuereder         
Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Principal Investigator: Dirk Schrijvers         
Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Principal Investigator: Yassine Lalami         
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Principal Investigator: Jean-Pascal Machiels         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Principal Investigator: Pol Specenier         
France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre Recruiting
Bordeaux, France, 33075
Principal Investigator: Laurence Digue         
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau Recruiting
Nantes, France, 44805
Principal Investigator: Frederic Rolland         
CHU de Nantes - Hotel Dieu Recruiting
Nantes, France
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Principal Investigator: Joel Guigay         
Assistance Publique - Hopitaux de Paris - Hopital Tenon Recruiting
Paris, France, 75020
Principal Investigator: Bertrand Baujat         
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Principal Investigator: Jean Pierre Delord         
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-Les-Nancy, France, 54519
Principal Investigator: Marie-Christine Kaminsky-Forrett         
Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Principal Investigator: Sebastian Ochsenreither         
Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic Recruiting
Jena, Germany, 07747
Principal Investigator: Orlando Guntinas-Lichius         
Hungary
National Institute Of Oncology Recruiting
Budapest, Hungary, 1122
Principal Investigator: Erika Hitre         
Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Principal Investigator: Cecilia Moro         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy
Principal Investigator: Laura Locati         
Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara Recruiting
Trento, Italy, 38100
Principal Investigator: Alessia Caldara         
Netherlands
Spaarne Gasthuis - Vrije Universiteit Medisch Centrum Recruiting
Amsterdam, Netherlands, 1007MB
Principal Investigator: Jan Buter         
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands, 9713 GZ
Principal Investigator: Sjoukje Oosting-Lenstra         
Radboud University Medical Center Nijmegen Recruiting
Nijmegen, Netherlands
Principal Investigator: Carla van Herpen         
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Principal Investigator: Lisa Licitra Fondazione IRCCS Istituto Nazionale Tumori
Study Chair: Kevin Harrington The Royal Marsden
  More Information

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01969578     History of Changes
Other Study ID Numbers: EORTC-1206
2013-000314-38 ( EudraCT Number )
Study First Received: September 24, 2013
Last Updated: August 11, 2017

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
salivary duct cancer
adenocarcinoma, NOS
androgen deprivation
androgen receptor

Additional relevant MeSH terms:
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Paclitaxel
Liposomal doxorubicin
Bicalutamide
Cisplatin
Carboplatin
Doxorubicin
Methyltestosterone
Triptorelin Pamoate
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Hormones

ClinicalTrials.gov processed this record on August 22, 2017