Clinical trial NCT00393822: A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Colon Cancer
Keywords: KGF
Palifermin
Oral Mucositis
Clinical Trial
Amgen
Oncology
Colon Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Grade ≥ 2 (WHO scale) oral mucositis
timeFrame: in Cycle 1 of chemotherapy treatment phase
Secondary outcomes:
measure: Incidence of chemotherapy (5-FU) dose reductions and dose delays
timeFrame: in Cycle 2 of chemotherapy treatment phase
measure: Average mouth and throat soreness (MTS) score
timeFrame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
measure: Duration of grade ≥ 2 (WHO scale) oral mucositis
timeFrame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
measure: Incidence and severity of adverse events
timeFrame: during Treatment Phase (6 cycles of chemotherapy)
measure: Changes in laboratory values
timeFrame: during Treatment Phase (6 cycles of chemotherapy)
measure: Incidence of serum anti-palifermin antibody formation
timeFrame: during Treatment Phase (6 cycles of chemotherapy)
measure: Progressive disease rate
timeFrame: at 6 months
measure: Incidence of secondary primary tumors
timeFrame: within long-term follow-up phase
measure: Incidence of other malignancies
timeFrame: within long-term follow-up phase
measure: Progression-free survival (PFS)
timeFrame: within long-term follow-up phase
measure: Overall survival (OS)
timeFrame: within long-term follow-up phase
measure: Incidence of grade ≥ 2 (WHO scale) oral mucositis
timeFrame: in Cycle 2 of chemotherapy treatment phase
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: