Clinical Study of Liposomal Paclitaxel in Chinese Patients

NCT00881101 | Unknown Phase 1

• 1 other identifier: LPS- PH I -01-2009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Keywords

Liposomal Paclitaxel; Maximum tolerated dose; Dose limiting toxicity

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose

  6 months

Secondary Outcomes (1)

• dose limiting toxicity

  6 months

Study Arms (1)

1

EXPERIMENTAL

Liposomal paclitaxel

Drug: Liposomal paclitaxel

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Sike Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The ethics committee of Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Jin Li, Dr.

  Cancer Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

CN (1)