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Trial record 72 of 722 for:    colon cancer AND 5-FU

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

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ClinicalTrials.gov Identifier: NCT00393822
Recruitment Status : Completed
First Posted : October 30, 2006
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: palifermin Drug: placebo Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Palifermin

Arm Intervention/treatment
Experimental: Palifermin
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
Other Name: KGF

Placebo Comparator: Control Group
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
Other Name: Pbo




Primary Outcome Measures :
  1. Incidence of Grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 1 of chemotherapy treatment phase ]

Secondary Outcome Measures :
  1. Incidence of chemotherapy (5-FU) dose reductions and dose delays [ Time Frame: in Cycle 2 of chemotherapy treatment phase ]
  2. Average mouth and throat soreness (MTS) score [ Time Frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase ]
  3. Duration of grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase ]
  4. Incidence and severity of adverse events [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ]
  5. Changes in laboratory values [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ]
  6. Incidence of serum anti-palifermin antibody formation [ Time Frame: during Treatment Phase (6 cycles of chemotherapy) ]
  7. Progressive disease rate [ Time Frame: at 6 months ]
  8. Incidence of secondary primary tumors [ Time Frame: within long-term follow-up phase ]
  9. Incidence of other malignancies [ Time Frame: within long-term follow-up phase ]
  10. Progression-free survival (PFS) [ Time Frame: within long-term follow-up phase ]
  11. Overall survival (OS) [ Time Frame: within long-term follow-up phase ]
  12. Incidence of grade ≥ 2 (WHO scale) oral mucositis [ Time Frame: in Cycle 2 of chemotherapy treatment phase ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393822


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00393822     History of Changes
Other Study ID Numbers: 20040122
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 2014
Keywords provided by Amgen:
KGF
Palifermin
Oral Mucositis
Clinical Trial
Amgen
Oncology
Colon Cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Mucositis
Stomatitis
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis
Mouth Diseases
Stomatognathic Diseases