Trial of Primary Prophylaxis With rhTPO Administered to Patients With High Risk Sarcoma Receiving Intensive Chemotherapy
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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) |
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 June 17, 2013