Study on Enzalutamide for Patients with Androgen Receptor Positive Salivary Gland Cancers
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT02749903
This clinical trial is testing the effects of the drug enzalutamide on salivary gland cancers that have androgen receptors. The study aims to see if enzalutamide can shrink the cancer by at least 30% in some patients, although it may also cause side effects.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug enzalutamide can effectively shrink salivary gland cancers that have androgen receptors. Enzalutamide is already approved for other types of cancer but not specifically for salivary gland cancer. Researchers hope that at least 1 in 5 patients will see their cancer shrink by 30% or more. The study will also look at how long patients live without the cancer getting worse, their overall survival, and any side effects they experience. Additionally, researchers will study the cancer's biology to understand why some patients respond better to the treatment than others.
Description
This study is a Phase II trial, meaning it is focused on evaluating how well enzalutamide works for patients with androgen receptor-positive salivary gland cancers. Since there are currently no standard treatments for this type of cancer, this trial is important for finding new options. The main goal is to see how many patients experience a significant reduction in their cancer size. Researchers will also track how long patients live without their cancer progressing, their overall survival, and any side effects from the treatment. The study will also explore the cancer's genetic and biological characteristics to identify factors that might predict a better response to enzalutamide. Patients will be monitored for up to three years after joining the study to gather comprehensive data on the treatment's effects.
Eligibility Criteria
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Documentation of Disease - Histologic Documentation: Histologically proven diagnosis of salivary cancer by central pathology review. Receptor status: AR expression detected by immunohistochemistry by central review.
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Disease status - Measurable disease as defined in the protocol. Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
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Prior Treatment
- Any number of prior lines of therapy
- No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration
- No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed).
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Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. A female of childbearing potent is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months). For women of childbearing potential only, a negative pregnancy test done ≤ 5 days prior to registration is required.
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Age ≥ 18 years
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Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
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No History of the following:
- prior brain metastases
- leptomeningeal disease
- seizures
- class 3 or 4 congestive heart failure
- uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg)
- major surgery ≤ 4 weeks of registration
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Required Initial Laboratory Values:
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet Count ≥ 100,000/mm3
- Creatinine ≤ 1.5 x ULN Upper Limit of Normal (ULN) OR
- Calculated Creatinine Clearance ≥ 30 mL/min
- Total Bilirubin ≤ 1.5 x ULN
- AST/ALT ≤ 3.0 x ULN
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Concomitant medications- Chronic concomitant treatment with strong CYP2C8 inhibitors is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug ≥ 14 days prior to registration.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
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