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

Phase 1
18 Years
70 Years
Open (Enrolling)
Solid Tumor

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Trial Information

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

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.

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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jin Li, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital of Fudan University


China: Ministry of Health

Study ID:

LPS- PH I -01-2009



Start Date:

April 2009

Completion Date:

December 2009

Related Keywords:

  • Solid Tumor
  • Liposomal Paclitaxel
  • Maximum tolerated dose
  • Dose limiting toxicity