Dose Escalation and Pharmacokinetic Study of Paclitaxel L... | NCT01994031

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose level A	Experimental	Paclitaxel liposome injection 135mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days	Drug: Paclitaxel liposome injection
Dose level B	Experimental	Paclitaxel liposome injection 175mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days	Drug: Paclitaxel liposome injection
Dose level C	Experimental	Paclitaxel liposome injection 210mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days	Drug: Paclitaxel liposome injection
Dose level D	Experimental	Paclitaxel liposome injection 250mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days	Drug: Paclitaxel liposome injection
Dose level E	Experimental	Paclitaxel liposome injection 300mg/m2 on day 1, First cycle 28 days and subsequent cycles each 21 days	Drug: Paclitaxel liposome injection
Comparator

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel liposome injection	Drug		Dose level A Dose level B Dose level C Dose level D Dose level E

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Measure	Description	Time Frame
Pharmacokinetic characters of paclitaxel liposome injection compared with paclitaxel injection	Peak Plasma Concentration(Cmax), peak time (Tmax), Half life(T1/2), Area under the plasma concentration versus time curve(AUC0-t), Clearance (CL/F), Apparent volume of distribution(Vd/F), Mean Residence Time (MRT),	0,during infusion 1.5h, 3h, after infusion 15min, 30min, 1h,2h,4h,8h,12h,24h,36h,48h,72 h

Eligibility Module

Eligibility Criteria

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

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes