Trial Information
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
Outcome Time Frame:
in Cycle 1 of chemotherapy treatment phase
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement
Study ID:
20040122
NCT ID:
NCT00393822
Start Date:
August 2005
Completion Date:
October 2018
Related Keywords:
- Colon Cancer
- KGF
- Palifermin
- Oral Mucositis
- Clinical Trial
- Amgen
- Oncology
- Colon Cancer
- Colonic Neoplasms
- Stomatitis
- Mucositis