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

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Paclitaxel liposome injection; Drug: Paclitaxel injection

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jifang Gong, MD; Phone Number: 008601088196561; Email: goodjf@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Ji Jiang
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jifang Gong; Phone Number: 00861088196561; Email: goodjf@163.com
    • Beijing, Beijing, China, 100142
      • Not yet recruiting
      • No.52 Fucheng Road, Haidian District,Beijing,
      • Principal Investigator: Lin Shen
      • Contact: Jifang Gong; Phone Number: 008601088196561; Email: goodjf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): August 27, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: paclitaxel; paclitaxel liposome injection
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: NJLYSK-LPS-2013-01