Trial record 3 of 230 for:    Thrombocytopenia: Clinical Trials

Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy

This study is currently recruiting participants.
Verified September 2013 by Chinese Society of Lung Cancer
Sponsor:
Information provided by (Responsible Party):
Yi-Long Wu, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT01319669
First received: March 21, 2011
Last updated: September 1, 2013
Last verified: September 2013
  Purpose

To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: recombinant human thrombopoietin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy With GC/GP Regimens for Non-small-cell Lung Carcinoma Using Recombinant Human Thrombopoietin (rhTPO)

Resource links provided by NLM:


Further study details as provided by Chinese Society of Lung Cancer:

Primary Outcome Measures:
  • minimum and maximum value of platelet count after chemotherapy [ Time Frame: nine weeks ] [ Designated as safety issue: No ]
    To evaluate the minimum and maximum value of platelet count after chemotherapy and the value of platelet count and their D-values comparing with the baseline values


Secondary Outcome Measures:
  • The duration when patient's platelet count remains below 50×109/L [ Time Frame: nine weeks ] [ Designated as safety issue: No ]
    The duration when patient's platelet count remains below 50×109/L, the time (in day) when patient's platelet count increases over 75×109/L and 100×109/L, the amount of platelet infused (number of units of apheresis platelet should be transformed into number of units of platelet concentrate)


Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
rhTPO is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.
Drug: recombinant human thrombopoietin
Recombinant human thrombopoietin injection in 15000U/ml/amp.
Other Name: rhTPO
Active Comparator: Control group
15000U of rhTPO is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11)
Drug: recombinant human thrombopoietin
Recombinant human thrombopoietin injection in 15000U/ml/amp.
Other Name: rhTPO

Detailed Description:

This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy.

Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients at the age of 18 to 75 years old
  2. Histologically or cytologically diagnosed NSCLC cases
  3. Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L
  4. Fit for chemotherapy (WBC ≥ 4.0×109/L;neutrophil count> 1.5×109/L;PLT ≥ 80×109/L;ALT ≤ 3 times the upper limit of normal range;AST ≤ 3 times the upper limit of normal range;TBil ≤ twice the upper limit of normal range;ECOG PS ≤ 2;without severe cardiopulmonary defects)
  5. Expected lifespan over 12 weeks
  6. With understanding ability and voluntarily sign informed consent form
  7. Be able to comply with the study and follow-up process

Exclusion Criteria:

  1. With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases
  2. With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled)
  3. With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months
  4. Breast-feeding or pregnant women
  5. Platelet count over 300×109/L
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319669

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Chongrui Xu, Doctor    86-20-83827812 ext 51221    xucr001@gmail.com   
Contact: Yilong Wu, Professor    86-20-83827812 ext 21187    syylwu@live.cn   
Sponsors and Collaborators
Chinese Society of Lung Cancer
Investigators
Principal Investigator: Yi-Long Wu, Professor Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Yi-Long Wu, Vice President of Guangdong General Hospital, Guangdong Academy of Medical Sciences, Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier: NCT01319669     History of Changes
Other Study ID Numbers: C-TONG1001
Study First Received: March 21, 2011
Last Updated: September 1, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Thrombocytopenia
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014