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Salivary Gland CancerPhase 2NCT01969578

Androgen Deprivation Therapy in Advanced Salivary Gland Cancer

A Phase 2 study testing bicalutamide + triptorelin, Cisplatin + Doxorubicin and Carboplatin + Paclitaxel in people with Salivary Gland Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 26 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Salivary Gland Cancer
What is being tested?
bicalutamide + triptorelin, Cisplatin + Doxorubicin and Carboplatin + Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
26 sitesin 8 countries
Study dates
24 Sep 2015to 16 Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

26 sites in 8 countries.

26 sites in 8 countries

France9 sites

  • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

    Bordeaux, 33075

  • Institut régional du Cancer Montpellier

    Montpellier

  • Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

    Nantes, 44805

  • CHU de Nantes - Hotel Dieu

    Nantes

  • Centre Antoine Lacassagne

    Nice, 06189

  • Assistance Publique - Hopitaux de Paris - Hopital Tenon

    Paris, 75020

  • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - Institut Claudius Regaud

    Toulouse, 31059

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif

Other trials in France

Belgium5 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

Other trials in Belgium

Germany3 sites

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

  • Universitaetsklinikum Jena-Radiation Therapy and Radiooncology Clinic

    Jena, 07747

  • Universitaetsklinikum Leipzig-Ambulanzen/Sprechstunden

    Leipzig

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • Azienda Provinciale per i Servizi Sanitari - Ospedale Santa Chiara

    Trento, 38100

Other trials in Italy

Netherlands3 sites

  • Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

    Amsterdam, 1007MB

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

  • Radboud University Medical Center Nijmegen

    Nijmegen

Other trials in Netherlands

Austria1 site

  • Medical University Vienna - General Hospital AKH

    Vienna, 1090

Other trials in Austria

Greece1 site

  • Athens University - Attikon University General Hospital

    Athens, 12462

Other trials in Greece

Hungary1 site

  • National Institute Of Oncology

    Budapest, 1122

Other trials in Hungary

About this study

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)

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.

Read the 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.

Being tested
bicalutamide + triptorelin, Cisplatin + Doxorubicin, Carboplatin + Paclitaxel
Keywords
salivary duct cancer, adenocarcinoma, NOS, androgen deprivation, androgen receptor
Medical subject headings
Salivary Gland Neoplasms, Adenocarcinoma, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamide + triptorelinDrug

  • Cisplatin + DoxorubicinDrug

  • Carboplatin + PaclitaxelDrug

Study groups in NCT01969578
Study groupRoleWhat they receive
ChemotherapyActive comparatorChemotherapy = either Cisplatin + Doxorubicin or Carboplatin + Paclitaxel Patients from cohort A (chemonaïve) may be randomized in this arm to receive chemotherapy
Receives: Drug: Cisplatin + Doxorubicin; Drug: Carboplatin + Paclitaxel
Androgen Deprivation Therapy (ADT)ExperimentalADT = 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.
Receives: Drug: bicalutamide + triptorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is a primary outcome for cohort A

    Measured: 37 months after First Patient In

  2. Response rate (RR)

    RR is a primary outcome for cohort B

    Measured: 37 months after First Patient In

Secondary outcomes (2)

  1. Response Rate (RR)

    RR is a secondary outcome for cohort A

    Measured: 37 months after First Patient In

  2. Progression Free Survival (PFS)

    PFS is a secondary outcome for cohort B

    Measured: 37 months after First Patient In

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2013 (estimated)
  2. Study start24 Sep 2015
  3. Primary completion23 Aug 2023
  4. Study completion16 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969578
Sponsor's protocol ID
EORTC-1206
Other IDs
2013-000314-38
Status last verified
Nov 2024
First submitted
24 Sep 2013
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bicalutamide + triptorelin, Cisplatin + Doxorubicin and Carboplatin + Paclitaxel in people with Salivary Gland Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 26 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France, Belgium, Germany, Italy, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 37 months after First Patient In). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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