Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
13 Years
N/A
Both
Sarcoma
Trial Information
Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
To evaluate the effectiveness of intravenous rhTPO vs. placebo as primary prophylaxis in
reducing the cumulative proportion of patients requiring platelet transfusion for severe
chemotherapy-induced thrombocytopenia (platelet count <15,000) during the first four study
cycles. To evaluate the severity and duration of thrombocytopenia and neutropenia associated
with rhTPO prophylaxis, the impact of rhTPO prophylaxis on health economics/cost
effectiveness, and patient quality of life. To assess the safety of multiple IV doses of
rhTPO.
Inclusion Criteria:
- Confirmed new diagnosis of moderate or high-grade sarcoma (except leiomyosarcoma of
gastrointestinal origin)
- Must have high risk disease by American Joint Committee on Cancer (AJCC) Staging
System Stage IIC, III, or IV
- Must have recovered from surgery for a minimum of 2 weeks
- Must be scheduled for a minimum of 4 cycles of AI therapy
- Must be 13 years or older
- Must have ECOG performance status of 0, 1, or 2.
- Must have life expectancy of at least 12 weeks.
- Left ventricular ejection fraction must be more than 50%.
- Laboratory data within normal limits.
Exclusion Criteria:
- Prior front-line standard or experimental therapy for sarcoma
- History of bone marrow and or peripheral blood progenitor cell transplantation
- Prior pelvic radiation or radiation therapy to more than 25% of bone marrow reserves
- Prior treatment with megakaryocyte growth and differentiation factor
- Prior treatment with rhTPO
- History of platelet disorder
- History of myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis
within the past 12 months
- Pregnant or lactating women
- Use of anticoagulants such as coumadin, heparin, etc.
- Known HIV or hepatitis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
CBC with diff. at least three times a week and daily if platelet less than 50,000. Chemistry, coagulation, urinalysis performed at baseline and at end of cycle if necessary.
Principal Investigator
Saroj Vadhan-Raj, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
DM00-435
NCT ID:
NCT00283582
Start Date:
June 2001
Completion Date:
November 2004
Related Keywords:
- Sarcoma
- Sarcoma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
