Clinical Study of Liposomal Paclitaxel in Chinese Patients

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00881101
• Other study ID #: LPS- PH I -01-2009
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: April 14, 2009
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2009
• Source: Nanjing Sike Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
China	The ethics committee of Cancer Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Sike Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose		6 months	Yes
Secondary	dose limiting toxicity		6 months	Yes