Clinical Study of Liposomal Paclitaxel in Chinese Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Liposomal paclitaxel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • The ethics committee of Cancer Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: from 18 to 70
2. Patients with solid tuomors at advanced stage must be histologically or cytologically confirmed ,and be suitable for treating with Paclitaxel Liposome solo
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS)is from 0 to 2
4. Patients who are expected to live at least 3 months
5. 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
6. Not using chemotherapeutics (including test drug)before the study trial at least 4 weeks
7. No obvious functional disturbance diseases of internal organs
8. Complying with the study protocol
9. Sign informed consent
10. No Previous anaphylactic reaction to hormone

Exclusion Criteria:

1. Allergy to any medication or foods; History of hypersensitivity reactions to the conventional dosage form of paclitaxel or correlate excipients
2. Active uncontrolled central nervous system metastasis
3. Severe complications that obviously influence the compliance of patients
4. Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
5. Taking other study medications or participating other clinical trial within 4w
6. Having radiation therapy or operation within 4w
7. Any non-remission toxicity ≥ CTC 1 in prior anticancer therapy(including radiation therapy) (except alopecie and hemoglobin)
8. Pregnant or lactant women; fertile patients not using effective contraception during study

9. 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
10. Others whom researchers regard not eligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
maximum tolerated dose	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
dose limiting toxicity	6 months

Collaborators and Investigators

• Sponsor: Nanjing Sike Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jin Li, Dr., Cancer Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): October 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: April 14, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2009
• Last Update Submitted That Met QC Criteria: April 14, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Maximum tolerated dose; Dose limiting toxicity; Liposomal Paclitaxel
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: LPS- PH I -01-2009