Clinical trial NCT01319669: Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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 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

Primary outcomes:
measure: minimum and maximum value of platelet count after chemotherapy
timeFrame: nine weeks
Secondary outcomes:
measure: The duration when patient's platelet count remains below 50×109/L
timeFrame: nine weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yi-Long Wu, Professor
role: PRINCIPAL_INVESTIGATOR
References: