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Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

NCT00267046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-05-16

Study results available
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Summary

Primary:

1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy.
2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.

Exploratory:

1. To evaluate the biologic effect of palifermin on oral mucosa.
2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
3. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.

Conditions

  • Sarcoma
  • Oral Mucositis

Interventions

DRUG

Palifermin

180 mcg/kg 3 days prior to chemotherapy

DRUG

Placebo

Single dose 3 days prior to chemotherapy

DRUG

Adriamycin (Doxorubicin)

30 mg/m\^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m\^2).

DRUG

Ifosfamide

2.5 g/m\^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m\^2); for patients receiving the AI Regimen.

DRUG

Vincristine

2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.

DRUG

Cisplatin

120 mg/m\^2 on day 0, for patients receiving the AP Regimen.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Saroj Vadhan-Raj, M.D. · University of Texas MDAnderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267046 on ClinicalTrials.gov