NCT00393822

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

October 26, 2006

Last Update Submit

July 14, 2014

Conditions

Colon Cancer

Keywords

KGFPaliferminOral MucositisClinical TrialAmgenOncologyColon Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Grade ≥ 2 (WHO scale) oral mucositis

    in Cycle 1 of chemotherapy treatment phase

Secondary Outcomes (12)

  • Incidence of chemotherapy (5-FU) dose reductions and dose delays

    in Cycle 2 of chemotherapy treatment phase

  • Average mouth and throat soreness (MTS) score

    in Cycle 1 and in Cycle 2 of chemotherapy treatment phase

  • Duration of grade ≥ 2 (WHO scale) oral mucositis

    in Cycle 1 and in Cycle 2 of chemotherapy treatment phase

  • Incidence and severity of adverse events

    during Treatment Phase (6 cycles of chemotherapy)

  • Changes in laboratory values

    during Treatment Phase (6 cycles of chemotherapy)

  • +7 more secondary outcomes

Study Arms (2)

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

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

Interventions

paliferminDRUG

dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles

Also known as: KGF
Palifermin
placeboDRUG

one bolus IV injection at 120 μg/kg/day of matched placebo

Also known as: Pbo
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsStomatitisNeoplasms

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

August 1, 2005

Primary Completion

December 1, 2007

Study Completion

March 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07