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

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00393822

Purpose

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.

Condition	Intervention	Phase
Colon Cancer	Drug: palifermin Drug: placebo	Phase II Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Palifermin Fibroblast growth factor 7

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Amgen:

Primary Outcome Measures:

Incidence of Grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 1 of chemotherapy treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 2 of chemotherapy treatment phase ] [ Designated as safety issue: No ]
Incidence of chemotherapy (5-FU) dose reductions and dose delays [ Time Frame: in Cycle 2 of chemotherapy treatment phase ] [ Designated as safety issue: No ]
Average mouth and throat soreness (MTS) score [ Time Frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase ] [ Designated as safety issue: No ]
Duration of grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ] [ Designated as safety issue: Yes ]
Changes in laboratory values [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ] [ Designated as safety issue: Yes ]
Incidence of serum anti-palifermin antibody formation [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ] [ Designated as safety issue: Yes ]
Progressive disease rate [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Incidence of secondary primary tumors [ Time Frame: within long-term follow-up phase ] [ Designated as safety issue: Yes ]
Incidence of other malignancies [ Time Frame: within long-term follow-up phase ] [ Designated as safety issue: Yes ]
Progression-free survival (PFS) [ Time Frame: within long-term follow-up phase ] [ Designated as safety issue: Yes ]
Overall survival (OS) [ Time Frame: within long-term follow-up phase ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	August 2005
Estimated Study Completion Date:	October 2018
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Palifermin: Experimental 50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.	Drug: palifermin dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
Control Group: Placebo Comparator 50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.	Drug: placebo one bolus IV injection at 120 μg/kg/day of matched placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393822

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20040122
Study First Received:	October 26, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00393822
Health Authority:	Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Czech Republic: Statni ustav pro kontrolu leciv; Hungary: National Institute of Pharmacy; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration

Keywords provided by Amgen:

KGF
Palifermin
Oral Mucositis
Clinical Trial

Amgen
Oncology
Colon Cancer

Study placed in the following topic categories:

Mouth Diseases
Digestive System Neoplasms
Mucositis
Stomatitis
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases

Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Stomatognathic Diseases
Gastroenteritis
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009