Clinical trial NCT00881101: Clinical Study of Liposomal Paclitaxel in Chinese Patients
Official title: Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Liposomal Paclitaxel
Maximum tolerated dose
Dose limiting toxicity
Lead sponsor: Nanjing Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 6 months
Secondary outcomes:
measure: dose limiting toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The ethics committee of Cancer Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Cancer Hospital of Fudan University
name: Jin Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References: