Clinical trial NCT00283621: Aranesp and Neulasta in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Official title: A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Keywords: Aranesp
Darbepoetin Alfa
Pegfilgrastim
Neulasta
Sarcoma
Adriamycin
Doxorubicin Hydrocholoride
Adriamycin PFS
Adriamycin RDF
Ifosfamide
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2006-01-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: CBC diff/platelet counts
timeFrame: Monitored at least twice a week and daily during severe myelosuppression.
measure: Iron Stores
timeFrame: Blood drawn at baseline during cycle 3 and at the end of study.
measure: Peripheral blood and bone marrows
timeFrame: Performed at baseline and post treatment.
Secondary outcomes:
measure: Neurocognitive functions and Symptom burden assessment
timeFrame: Assessed at baseline, after 3 cycles of treatment and at the end of the study.
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MDAnderson Cancer Center
state: Texas
Study officials:
affiliation: UT MDAnderson Cancer Center
name: Saroj Vadhan-Raj, M.D.
role: PRINCIPAL_INVESTIGATOR
References: