Clinical trial NCT00283582: Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
Official title: Randomized Double-blind Placebo-controlled Trial of Primary Prophylaxis With Recombinant Human Thrombopoietin Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2006-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Intensive chemotherapy is often associated with low platelet counts often requiring platelet transfusions to maintain platelet counts. In previous clinical studies administration of rhTPO has been demonstrated to increase platelet counts.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Saroj Vadhan-Raj, M.D.
role: PRINCIPAL_INVESTIGATOR
References: