Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose (MTD)of paclitaxel liposome injection and to compare the pharmacokinetic characters between paclitaxel liposome injection and paclitaxel injection and to value the effectiveness for cancer treatment.

Official Title
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Dose Escalation and Pharmacokinetic Study of Paclitaxel Liposome Injection in Treating Patients With Advanced Solid Tumor After Failure From Conventional Treatments

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: Paclitaxel liposome injection
* Drug: Paclitaxel injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient willing to sign an Investigational Review Board(IRB) approved written informed consent document patient age: 18 years -75years patient must have histologically confirmed solid tumor patient must have uncurable and unresectable solid tumor of advanced stages patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 patient must have a life expectancy at least 12 weeks patient must have at least one lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 patient must have progress or recurrence after at least one chemotherapy regimen for advanced stage patient must have adequate marrow,hepatic and renal function: defined as ANC≥2.0 × 109/L，PLT ≥10 ×109/dL, Hb ≥ 9g/dL;GOT/GPT≤2.5×ULN；Toltle bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN or Creatinine clearance≥40ml/min(according to Cockcroft-Gault； patient must have the left ventricular ejection fraction (LVEF)≥50% confirmed by ultrasonic heart scanning women must have the negative pregnancy test; women and men must agree to use adequate contraception Exclusion Criteria: patient must non have received any other antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, biological therapy, immunotherapy and any other investigational agent within 4 weeks prior to starting study patient must non have any pre-existing toxity from prior antitumor therapy (any≥ grade 2, any≥1 peripheral neuropathy, excluding alopecia) patient must non have uncontrolled cerebral metastases patient must non have any uncontrolled heart illness including, but not limited to, ongoing symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, arterial hypertension (≥180/110), heart failure and myocardial infarction within 6 months prior to starting study Patient must not have a history of a malignancy tumor except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix for at least 5 years patient must non have any serious illness including, but not limited to hepatic, renal, respiratory and uncontrolled diabetes mellitus patient must non have psychiatric illness/social situations that would limit compliance with study requirements. patient must non have active or uncontrolled infection including, but not limited to tuberculosis,HIV,HBV, HCV Patient must non be receiving any other antitumor agent patient must non be pregnant and/or breastfeeding patient must non be receiving protease inhibitors,inhibitors of CYP3A4,antifungal agents and inducing agent of CYP3A4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level A<br>Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days | Drug: Paclitaxel liposome injection<br> <br> * Other names: LIPUSU®;|
| Experimental: Dose level B<br>Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days | Drug: Paclitaxel liposome injection<br> <br> * Other names: LIPUSU®;|
| Experimental: Dose level C<br>Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days | Drug: Paclitaxel liposome injection<br> <br> * Other names: LIPUSU®;|
| Experimental: Dose level D<br>Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days | Drug: Paclitaxel liposome injection<br> <br> * Other names: LIPUSU®;|
| Experimental: Dose level E<br>Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days | Drug: Paclitaxel liposome injection<br> <br> * Other names: LIPUSU®;|
| Active Comparator: Comparator<br>Paclitaxel injection 175mg/m2 on day 1, each 21 days | Drug: Paclitaxel injection<br> <br> * Other names: Taxol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose(MTD)of paclitaxel liposome injection | Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0) | completion of cycle 1(28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose-limiting toxicities(DLTs) of paclitaxel liposome injection | Graded and described using National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0) | completion of cycle 1 (28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paclitaxel liposome injection, paclitaxel