A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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