Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with recurrent and/or metastatic salivary grand carcinoma
- Conditions
- HER2 and/or androgen receptor positive recurrent and/or metastatic salivary gland carcinoma
- Registration Number
- JPRN-UMIN000009437
- Lead Sponsor
- International University of Health and Welfare Mita Hospital
- Brief Summary
https://academic.oup.com/annonc/article/29/4/979/4683452 http://ascopubs.org/doi/full/10.1200/JCO.18.00545
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
<Docetaxel and Trastuzumab> Prior docetaxel or trastuzumab treatment was not allowed. The cumulative dose of anthracycline derivatives would not exceed 360 mg/m2 (converted into the dose of doxorubicin). Other exclusion criteria included , uncontrolled concomitant disease, active concomitant malignancy, a history of myocardial infarction or clinically important cardiovascular disease, a left ventricular ejection fraction (LVEF) less than 50% or below the upper limit of normal, New York Heart Association functional classification II to IV, suspected infection with fever, motor paralysis or peripheral neuropathy; pleural or pericardial effusion that required treatment, symptomatic brain metastasis, edema of grade 2 or higher, interstitial pneumonia or lung fibrosis, or allergy to polysorbate 80, pregnant women or women who might be pregnant. <MAB> Prior Bicalutamide or leuprorelin acetate treatment was not allowed. Other exclusion criteria included , uncontrolled concomitant disease, active concomitant malignancy, suspected infection with fever, motor paralysis or peripheral neuropathy; pleural or pericardial effusion that required treatment, edema of grade 2 or higher, interstitial pneumonia or lung fibrosis, pregnant women or women who might be pregnant or Physician judged improper to entry this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate Safety
- Secondary Outcome Measures
Name Time Method Progression-free survival