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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Liposomal paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal paclitaxel | Drug | All Patients will receive liposomal paclitaxel (starting at a dose of 190mg/m2,3h,ivgtt,at d1)each cycle for 1 cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| dose limiting toxicity | 6 months |
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Inclusion Criteria:
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:
Others whom researchers regard not eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jin Li, Dr. | Cancer Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The ethics committee of Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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