Clinical Study of Liposomal Paclitaxel in Chinese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Nanjing Sike Pharmaceutical Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nanjing Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00881101
First received: April 14, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Solid Tumor
Drug: Liposomal paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalation Study of Liposomal Paclitaxel in Chinese Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Nanjing Sike Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • maximum tolerated dose [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • dose limiting toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881101

Locations
China, Shanghai
The ethics committee of Cancer Hospital of Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Nanjing Sike Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jin Li, Dr. Cancer Hospital of Fudan University
  More Information

No publications provided

Responsible Party: Jin Li, Dr., Cancer Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT00881101     History of Changes
Other Study ID Numbers: LPS- PH I -01-2009
Study First Received: April 14, 2009
Last Updated: April 14, 2009
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Sike Pharmaceutical Co., Ltd.:
Liposomal Paclitaxel
Maximum tolerated dose
Dose limiting toxicity

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014