CompletedPhase 2/3

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

100 participantsStarted 2005-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of Grade ≥ 2 (WHO scale) oral mucositis

Timeframe: in Cycle 1 of chemotherapy treatment phase

Trial details

NCT IDNCT00393822

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

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