Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00283582
First received: January 27, 2006
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: rhTPO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.

Enrollment: 50
Study Start Date: June 2001
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283582

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Saroj Vadhan-Raj, M.D. UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00283582     History of Changes
Other Study ID Numbers: DM00-435
Study First Received: January 27, 2006
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014