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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01319669
• Other study ID #: C-TONG1001
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 21, 2011
• Last updated: March 2, 2017
• Start date: February 2011
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Chinese Society of Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Thrombocytopenia

Intervention

Drug:
• recombinant human thrombopoietin
Recombinant human thrombopoietin injection in 15000U/ml/amp.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Society of Lung Cancer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	minimum and maximum value of platelet count after chemotherapy	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	nine weeks
Secondary	The duration when patient's platelet count remains below 50×109/L	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)	nine weeks