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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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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

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