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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393822
• Other study ID #: 20040122
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 26, 2006
• Last updated: July 14, 2014
• Start date: August 2005
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et EnvironnementCzech Republic: Statni ustav pro kontrolu lecivHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Colon Cancer
• Mucositis
• Stomatitis

Intervention

Drug:
• palifermin
dose of 120 µg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
• placebo
one bolus IV injection at 120 µg/kg/day of matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

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

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling