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

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Amgen

Status and phase

Completed
Phase 3
Phase 2

Conditions

Colon Cancer

Treatments

Drug: placebo
Drug: palifermin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00393822
20040122

Details and patient eligibility

About

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.

Full 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 reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Palifermin
Experimental group
Description:
50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
Treatment:
Drug: palifermin
Control Group
Placebo Comparator group
Description:
50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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