Clinical trial NCT00038311: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Official title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy

Exclusion Criteria:

* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Primary outcomes:
measure: To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Secondary outcomes:
measure: Identify the effect of rhTPO on the number of platelet transfusions.
measure: Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
measure: Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
measure: Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
measure: Assess the safety of multiple IV doses of rhTPO.
measure: Determine the occurrence and clinical implications of any anti-TPO antibodies.
measure: Assess the antitumor activity of AI chemotherapy.
measure: Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
measure: Evaluate the impact of rhTPO prophylaxis on patient quality of life.
measure: Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Radnor
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: