Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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27 October 2014 |
Main ID: |
EUCTR2004-005007-14-BE |
Date of registration:
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02/08/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A study to evaluate the effects of palifermin in reducing mouth ulceration in Subjects with advanced colon cancer
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Scientific title:
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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 |
Date of first enrolment:
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12/05/2005 |
Target sample size:
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100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005007-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Belgium
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Czech Republic
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Hungary
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Poland
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Contacts
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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N/A |
Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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N/A |
Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Oral Mucositis MedDRA version: 14.1
Level: LLT
Classification code 10028130
Term: Mucositis oral
System Organ Class: 100000004856
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Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
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Intervention(s)
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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)
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Primary Outcome(s)
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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
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Timepoint(s) of evaluation of this end point: 1 week (as per assessment at cycle 1)
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Primary end point(s): Incidence of grade = 2 (WHO scale) OM in cycle 1
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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
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Secondary Outcome(s)
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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
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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.
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Secondary ID(s)
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20040122
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2004-005007-14-HU
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Source(s) of Monetary Support
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Amgen Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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