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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-005007-14-CZ
• Date of registration: 09/06/2005
• Prospective Registration: No
• Primary sponsor: Amgen Ltd
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 27/05/2005
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005007-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
• Written informed consent

• Histologically confirmed diagnosis of colon adenocarcinoma

• Newly diagnosed stage 2B or 3 (AJCC staging criteria) resected colon carcinoma and a candidate for 5-FU/LV treatment

• Subjects 18 years of age or older

• ECOG performance status = 1

• Baseline Laboratory Assessments:
Hemoglobin (Hgb) = 10 g/dL
Absolute neutrophil count (ANC) = 1.5 x 10e9/L
Platelet count = 100 x 10e9/L
Serum bilirubin = 1.5 x institutional upper limit of normal (ULN)
Serum creatinine = 2.0 mg/dL
Serum AST = 5x ULN

• Females of childbearing potential: negative serum or urine pregnancy test

• Subjects with reproductive capability must agree to practice adequate contraception methods

• Absence of other serious concurrent medical illness

• Willingness to participate in subsequent long-term follow up study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 OM or xerostomia

• Presence of active diarrhea > grade 1 according to CTCAE v. 3 grading criteria within 3 days prior to randomization

• History of pancreatitis

• Four weeks or less since completion of treatment using an investigational product or device in another clinical study or presence of any unresolved toxicity from previous treatment

• Subjects who would be unwilling/unable to complete daily patient-reported outcome (PRO) questionnaires

• Pregnant or breast-feeding women

• Subjects of childbearing potential not using adequate contraceptive precautions

• Known sensitivity to any of the products administered during dosing, including E coli-derived products

• Known to be sero-positive for human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV)

• Previous treatment on this study or with other keratinocyte growth factors

• Psychological, social, familial, or geographical reasons that would prevent regular follow-up

• Compromised ability of the subject to give written informed consent and/or to comply with study procedures

• Refusal to sign an informed consent form to participate in this study or, if applicable, refusal to sign the hospital information release


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Oral mucositis (OM) associated with multi-cycle chemotherapy with fluoropyrimidine containing regimens

Intervention(s)

Product Name: Palifermin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Palifermin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.25-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: To evaluate the effect of palifermin on the incidence of Grade = 2 OM induced by
adjuvant chemotherapy in subjects with stage 2B and 3 locally advanced colon cancer in cycle 1, when administered as a single dose of 120 µg/kg three days prior to each 4-week cycle of 5-FU and leucovorin

Primary end point(s): • Incidence of grade = 2 (World Health Organization [WHO] scale) OM in cycle 1

Secondary Objective: To assess the safety and tolerability of palifermin administered as a single dose of 120 µg/kg IV before each cycle of 5-FU and leucovorin

To evaluate the effect of palifermin on patient-reported mouth and throat soreness (MTS)

To evaluate the duration of Grade = 2 OM

To evaluate 5-FU dose reductions/delays

To evaluate the long-term effects of palifermin on disease outcome and survival

To evaluate the incidence of Grade = 2 OM in cycle 2

Secondary ID(s)

2004-005007-14-HU

20040122