Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients
NCT ID: NCT01611961
Last Updated: 2014-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
35 participants
INTERVENTIONAL
2012-08-31
2014-12-31
Brief Summary
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Detailed Description
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This study is designed to determine the following:
* The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
* The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
* Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DT-LM
Docetaxel Lipid Microsphere (DT-LM)
DT-LM
Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.
Taxotere
Commerical Product
docetaxel
Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks
Interventions
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DT-LM
Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.
docetaxel
Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
3. Have recovered from acute toxicities of prior treatment:
* 4 weeks must have elapsed since receiving any investigational agent.
* 4 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas).
* 4 weeks must have elapsed since any prior surgery.
4. Be in adequate condition as evidenced by the following clinical laboratory values:
* Absolute neutrophil count (ANC) ≥1,500/mm3.
* Platelets ≥ 80,000/mm3.
* Hemoglobin ≥ 9.0 g/dL.
* WBC ≥ 4,000/mm3.
* Total bilirubin ≤ 2.5 x institutional upper limit normal (ULN).
* Transaminases AST (SGOT) and ALT (SGPT) ≤ 1.5 times ULN or ≤ 5 times ULN (liver metastasis).
* Serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.
5. both female and male patients must use adequate methods of contraception.
6. Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.
Exclusion Criteria
2. having failed a docetaxel-containing regimen or Having known non-controllable hypersensitivity to docetaxel or lipid microsphere.
3. Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
4. Unstable or uncontrolled cardiac disease or hypertension.
5. With other serious internal diseases, uncontrolled infection or uncontrolled diabetes.
6. With Symptomatic brain metastasis not controlled.
7. Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
8. Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
9. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
10. Female patients who are pregnant or breast-feeding.
11. Unwilling or unable to follow protocol requirements.
12. With history of serious allergic or allergy.
13. Not fit for the clinical trial judged by the investigator.
18 Years
65 Years
ALL
No
Sponsors
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Shenyang Pharmaceutical University
OTHER
Responsible Party
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Shi Yuankai, Ph.D
the Director of Oncology Department
Principal Investigators
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Xing Tang, Ph.D
Role: STUDY_DIRECTOR
Shenyang Pharmaceutical University
Locations
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Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Yuankai Shi
Role: CONTACT
Phone: 86-10-87788121
Facility Contacts
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Yuankai Shi
Role: primary
Other Identifiers
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SYPHU-DT-LM-01
Identifier Type: -
Identifier Source: org_study_id