Clinical Study of Liposomal Paclitaxel in Chinese Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.

Detailed Description
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There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.

Official Title
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Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Liposomal paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: from 18 to 70 Patients with solid tuomors at advanced stage must be histologically or cytologically confirmed ,and be suitable for treating with Paclitaxel Liposome solo Eastern Cooperative Oncology Group (ECOG) performance status (PS)is from 0 to 2 Patients who are expected to live at least 3 months Laboratory tests before the study: white blood count (WBC)≥4,000/mm³,absolute neutrophil count (ANC) ≥1,500/mm³, platelet count ≥100,000/mm³, hemoglobin≥9.0 g/dL, aspartate aminotransferase AST (sGOT) and alanine aminotransferase ALT(sGPT)≤2.5 times of normal value upper limit，serum creatinine≤1.0 time of normal value upper limit，total bilirubin≤1.5 times of normal value upper limit Not using chemotherapeutics (including test drug)before the study trial at least 4 weeks No obvious functional disturbance diseases of internal organs Complying with the study protocol Sign informed consent No Previous anaphylactic reaction to hormone Exclusion Criteria: Allergy to any medication or foods; History of hypersensitivity reactions to the conventional dosage form of paclitaxel or correlate excipients Active uncontrolled central nervous system metastasis Severe complications that obviously influence the compliance of patients Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria Taking other study medications or participating other clinical trial within 4w Having radiation therapy or operation within 4w Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin) Pregnant or lactant women; fertile patients not using effective contraception during study No chief organ functional disturbance or diseases: abnormal liver and renal functions myocardial infarction active heart disease neuropathy or mental diseases including dementia or epilepsy blind、deaf、dumb or extremity disability known infection active diffuse intravascular coagulation Others whom researchers regard not eligible for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Liposomal paclitaxel | Drug: Liposomal paclitaxel<br>* All Patients will receive liposomal paclitaxel (starting at a dose of 190mg/m2,3h,ivgtt,at d1)each cycle for 1 cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose limiting toxicity |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposomal Paclitaxel, Maximum tolerated dose, Dose limiting toxicity