Antineoplastic Drugs in Elderly Patients
Study Details
Study Description
Brief Summary
The purpose is to study the population pharmacokinetics, effectiveness and safety of antineoplastic drugs (Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib, Imatinib, Lapatinib, etc) in elderly patients and recommend optimized dosage regimens.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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treatment The use of antineoplastic agents depends on the clinical practice. |
Drug: Busulfan, Paclitaxel, Afatinib, Ceritinib, Crizotinib (Antineoplastic drugs)
As part of routine treatment.
Other Names:
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Outcome Measures
Primary Outcome Measures
- The peak plasma drug concentration of antineoplastic drugs. [at (0-4) hours after administration]
To detect the peak plasma drug concentration of antineoplastic drugs.
- The random plasma drug concentration of antineoplastic drugs. [at (4-10) hours after administration]
To detect the random plasma drug concentration of antineoplastic drugs.
- The trough plasma drug concentration of antineoplastic drugs. [at (1-2) hours before the next administration]
To detect the trough plasma drug concentration of antineoplastic drugs.
Secondary Outcome Measures
- Objective ResponseRate ,ORR [Enrollment to end of treatment up to 5 years]
- Overall Survival ,OS [First day of study treatment to the date of death due to any cause, assessed up to 5 years]
- Progression-free Survival ,PFS [First day of study treatment to the date of disease progression or death due to any cause, assessed up to 5 years]
- Time to Progression ,TTP [Enrollment to end of treatment up to 5 years]
- The incidence of adverse drug reaction [Enrollment to end of treatment up to 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be enrolled in the study:
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Age ≥65 years old;
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Diagnosed with cancer;
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Using antineoplastic drugs for treatment.
Exclusion Criteria:
Subjects with any of the following criteria will not be enrolled in this study:
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Patients who are expected to die within 48 hours;
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Patients with allergy to antineoplastic drugs;
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Patients receiving other investigational drugs;
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Other factors that the researcher considers unsuitable for inclusion.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Shandong Provincial Qianfoshan Hospital | Jinan | Shandong | China |
Sponsors and Collaborators
- Shandong University
- Qianfoshan Hospital
- The Second Hospital of Shandong University
- The Affiliated Hospital of Qingdao University
Investigators
- Study Chair: Zhao Wei, Ph.D, Qianfoshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Elderly-Antineoplastic drugs