Androgen Deprivation Therapy in Advanced Salivary Gland Cancer
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Salivary Gland Cancer |
| Intervention | Drug: bicalutamide + triptorelin Drug: Cisplatin + Doxorubicin Drug: Carboplatin + Paclitaxel |
| Phase | Phase 2 |
| Sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
| Responsible Party | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier | NCT01969578 |
| First Received | September 24, 2013 |
| Last Updated | February 28, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 24, 2013 |
|---|---|
| Last Updated Date | February 28, 2014 |
| Start Date | June 2014 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Androgen Deprivation Therapy in Advanced Salivary Gland Cancer |
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| 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) |
| 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 | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Salivary Gland Cancer |
| Intervention | Drug: bicalutamide + triptorelin Drug: Cisplatin + Doxorubicin Drug: Carboplatin + Paclitaxel |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 152 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2017 |
| Eligibility 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 left ventricular ejection fraction (LVEF) ≥ 50% and a clinically normal 12 lead ECG Exclusion Criteria: - 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; - history of allergic reactions attributed to compounds of similar chemical or biological composition to cis/carboplatin, paclitaxel, doxorubicin, bicalutamide or triptorelin; - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Leslie Herman +32 2 774 15 11 leslie.herman@eortc.be |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01969578 |
|---|---|
| Other Study ID Numbers | EORTC-1206-HNCG |
| Has Data Monitoring Committee | Yes |
| Information Provided By | European Organisation for Research and Treatment of Cancer - EORTC |
| Study Sponsor | European Organisation for Research and Treatment of Cancer - EORTC |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Lisa Licitra Fondazione IRCCS Istituto Nazionale TumoriStudy Chair: Alan Ho Memorial Sloan-Kettering Cancer CenterStudy Chair: Kevin Harrington The Royal Marsden |
| Verification Date | February 2014 |