Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00283621
First received: January 27, 2006
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
| Condition | Intervention |
|---|---|
|
Sarcoma |
Drug: Aranesp (darbepoetin alfa) Drug: Neulasta (pegfilgrastim) Drug: Adriamycin Drug: Ifosfamide |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide |
Resource links provided by NLM:
Drug Information available for:
Ifosfamide
Doxorubicin
Doxorubicin hydrochloride
Pegfilgrastim
Darbepoetin Alfa
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- CBC diff/platelet counts [ Time Frame: Monitored at least twice a week and daily during severe myelosuppression. ] [ Designated as safety issue: No ]
- Iron Stores [ Time Frame: Blood drawn at baseline during cycle 3 and at the end of study. ] [ Designated as safety issue: No ]
- Peripheral blood and bone marrows [ Time Frame: Performed at baseline and post treatment. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neurocognitive functions and Symptom burden assessment [ Time Frame: Assessed at baseline, after 3 cycles of treatment and at the end of the study. ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | November 2002 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
|
Drug: Aranesp (darbepoetin alfa)
Drug: Neulasta (pegfilgrastim)
Drug: Adriamycin
Other Names:
Drug: Ifosfamide
Other Name: Ifex
|
Detailed Description:
The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated
- Must be between 18-65 years of age
- Women of childbearing potential should use effective contraceptive measures
- Adequate hematologic, renal, and hepatic functions
- Karnofsky performance status above or equal to 80
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with comorbid condition which renders patients at high risk of treatment complication
- Patients with metastatic disease to CNS
- Patients with significant cardiac abnormalities
- History of seizure disorder in the past 5 years
- Patient has received any packed red blood cell transfusion within 2 weeks before study entry
- Prior surgery or radiation therapy within 2 weeks of study entry
- History of prior chemotherapy for sarcomas
- Iron deficiency
- Hypersensitivity to E.coli derived products
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283621
Locations
| United States, Texas | |
| UT MDAnderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
| Principal Investigator: | Saroj Vadhan-Raj, M.D. | UT MDAnderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00283621 History of Changes |
| Other Study ID Numbers: | ID02-326 |
| Study First Received: | January 27, 2006 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Aranesp Darbepoetin Alfa Pegfilgrastim Neulasta Sarcoma |
Adriamycin Doxorubicin Hydrocholoride Adriamycin PFS Adriamycin RDF Ifosfamide |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Isophosphamide mustard Ifosfamide Darbepoetin alfa Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013