A study to evaluate the effects of palifermin in reducing mouth ulceration in Subjects with advanced colon cancer

• Register: EUCTR
• Last refreshed on: 23 December 2013
• Main ID: EUCTR2004-005007-14-HU
• Date of registration: 18/03/2005
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: A study to evaluate the effects of palifermin in reducing mouth ulceration in Subjects with advanced colon cancer
• 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: 20/05/2005
• 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: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Czech Republic, Hungary, Poland

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Disease Related
• Histologically confirmed diagnosis of colon adenocarcinoma
• Newly diagnosed stage 2B or 3 (AJCC staging criteria; see Appendix F) resected colon carcinoma and a candidate for 5-FU/LV treatment
Demographic
• 18 years of age or older
• ECOG performance status = 1
Baseline Laboratory
• Hemoglobin (Hgb) = 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
• Absolute neutrophil count (ANC) = 1.5 x 109/L without growth factor use in the 2 weeks before study randomization
• Platelet count = 100 x 109/L
• Serum bilirubin = 1.5 x institutional upper limit of normal (ULN)
• Serum creatinine = 2.0 mg/dL
• Serum AST = 5 x ULN
• Females of childbearing potential: negative serum or urine pregnancy test
Ethical
• Subject must give written informed consent before participating in any study-specific procedure
General
• 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 51
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion criteria:
Disease Related
• Previous therapy (eg, 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
• Presence of active diarrhea > grade 1 according to CTCAE v. 3 grading criteria within three days prior to randomization
• History of pancreatitis
Medication/Prior Treatment
• 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
• Known sensitivity to any of the products administered during dosing, including E. coli-derived products
• Previous treatment on this study or with other keratinocyte growth factors
Laboratory
• Known to be sero-positive for human immunodeficiency virus (HIV) or Hepatitis C Virus (HCV)
General
• Subjects who would be unwilling/unable to complete daily patient-reported outcome questionnaires
• Subjects of childbearing potential not using adequate contraceptive precautions
• Pregnant or breast-feeding women
• 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 form


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

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Oral Mucositis
MedDRA version: 16.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856

Intervention(s)

Product Name: Palifermin (Kepivance)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: palifermin
Current Sponsor code: 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 bolus use (Noncurrent)

Primary Outcome(s)

Primary end point(s): Incidence of grade = 2 (WHO scale) OM in cycle 1

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

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

Timepoint(s) of evaluation of this end point: 1 week (as per assessment at cycle 1)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 1 and week 2

After completion of, or withdrawal from, the treatment phase, subjects
will continue onto the long-term follow-up phase and will be monitored
for disease progression, second primary tumors, other malignancies
and overall survival until considered lost to follow-up, death, or for up
to 5 years from the last subject randomized.

Secondary end point(s): Secondary:
• Incidence of grade = 2 (WHO scale) OM in cycle 2
• Average MTS score (OMDQ Question 2) in cycle 1
• Average MTS score (OMDQ Question 2) in cycle 2
• Incidence of 5-FU dose reductions and dose delays in cycle 2
• Duration of Grade = 2 (WHO scale) OM in cycle 1
• Duration of Grade = 2 (WHO scale) OM in cycle 2

Secondary ID(s)

20040122

Source(s) of Monetary Support

Amgen Inc