Phase 2
N=55
Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
Malignant Salivary Gland Neoplasm · Recurrent Salivary Gland Carcinoma · Salivary Gland Adenoid Cystic Carcinoma · Stage IV Major Salivary Gland Cancer AJCC v7
Bottom Line
View on ClinicalTrials.gov: NCT00859937 ↗Enrolled (actual)
55
Serious AEs
37.0%
Results posted
Apr 2015
Primary outcome: Primary: Response Rate — 0; 0; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dasatinib (Drug); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
0; 0; 1; 0; 20; 7 | — |
| PRIMARY Progression-free Survival |
4.8; 2.7 | — |
| SECONDARY Overall Survival |
14.5; 4.8 | — |
| SECONDARY Changes in Laboratory Correlates |
— | — |
Summary
This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed malignant salivary gland tumor (MSGT), including one of the following histologic subtypes:
- Adenoid cystic carcinoma (ACC) with c v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (Kit) overexpression or non-ACC MSGT that is not amenable to potentially curable surgery or radiation
- c-KIT overexpression in ACC patients is defined as cluster of differentiation (CD) 117 staining by immunohistochemistry (IHC) in 25% of tumor cells
- No stipulation for c-KIT overexpression is not required for non-ACC MSGT patients
- Patients must have radiographically measurable disease; radiographically measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- Patients must have evidence of disease progression (objective growth of existing tumors) within 4 months of study entry
- No known brain metastases, unless patient meets both of the following criteria:
- Neurologic status stable for >= 8 weeks after completion of definitive local therapy (surgery or radiotherapy)
- No neurologic dysfunction that would confound study results
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 OR Karnofsky performance status (PS) >= 60%
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelet >= 100,000/mcL
- Hemoglobin >= 9 g/dL
- Serum calcium = = 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; all women of childbearing potential must have a negative pregnancy test prior to receiving dasatinib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; at least 4 weeks must have elapsed since any major surgery
- Patients may not be receiving any other investigational agents
- No prior treatment with any other targeted agents that inhibit vascular endothelial growth factor receptor (VEGFR), Breakpoint cluster region (BCR) ABL proto-oncogene 1, non-receptor tyrosine kinase (ABL), c-Src, c-KIT, platelet-derived growth factor (PDGF) beta receptor, or ephrin type-A receptor 2 (EPHA2) (e.g., imatinib mesylate)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib
- Patients with corrected QT interval (QTc) prolongation (defined as a QTc interval equal to or greater than 500 msec), serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia greater than or equal to 3 beats in a row) or other significant echocardiogram (ECG) abnormalities are excluded
- Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for intravenous [IV] alimentation, or active peptic ulcer disease) that impairs their ability to swallow and retain dasatinib tablets are excluded
- Patients with any of the following conditions are excluded:
- Serious or non-healing wound, ulcer, or bone fracture
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses within the past 28 days
- Any history of cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months
- History of myoc
Data sourced from ClinicalTrials.gov (NCT00859937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.