Status:
COMPLETED
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer
Lead Sponsor:
Amgen
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subj...
Detailed Description
This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would red...
Eligibility Criteria
Inclusion
- History of newly diagnosed histologically confirmed resected colon cancer (American Joint Committee on Cancer \[AJCC\] Stage 2B or 3) and a candidate for adjuvant 5-FU and Leucovorin
- Eastern Cooperative Oncology Group performance status ≤ 1
- Functional hematopoietic and hepato-renal systems
Exclusion
- Previous therapy (e.g. chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection
- Presence or history of any other primary malignancy
- Presence of active or chronic oral mucositis or xerostomia
- Previous treatment with other keratinocyte growth factors
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00393822
Start Date
August 1 2005
End Date
March 1 2014
Last Update
July 15 2014
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