Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
Public ClinicalTrials.gov record NCT00267046. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase II Study to Evaluate the Pharmacokinetics, Safety, and Obtain a Preliminary Efficacy Assessment of Palifermin in Patients With Sarcoma Receiving Multicycle Chemotherapy With Doxorubicin and Ifosfamide
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00267046
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
- Palifermin Drug
- Placebo Drug
- Adriamycin (Doxorubicin) Drug
- Ifosfamide Drug
- Vincristine Drug
- Cisplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 15 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2005 (Type not available)
- Primary completion
- Jul 2009 (Actual)
- Completion
- Jul 2009 (Actual)
- Last update posted
- May 16, 2012
2005 – 2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| U.T.M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00267046, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2012 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00267046 live on ClinicalTrials.gov.