Colon CancerPhase 2/3NCT00393822
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer
A Phase 2/3 study testing palifermin in people with Colon Cancer, run by Amgen.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- palifermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- palifermin, placebo
- Keywords
- KGF, Palifermin, Oral Mucositis, Clinical Trial, Amgen, Oncology, Colon Cancer
- Medical subject headings
- Colonic Neoplasms, Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliferminDrug
Also called KGF
dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles
placeboDrug
Also called Pbo
one bolus IV injection at 120 μg/kg/day of matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Palifermin | Experimental | 50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
Measured: in Cycle 1 of chemotherapy treatment phase
Secondary outcomes (12)
Incidence of chemotherapy (5-FU) dose reductions and dose delays
Measured: in Cycle 2 of chemotherapy treatment phase
Average mouth and throat soreness (MTS) score
Measured: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Duration of grade ≥ 2 (WHO scale) oral mucositis
Measured: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Incidence and severity of adverse events
Measured: during Treatment Phase (6 cycles of chemotherapy)
Changes in laboratory values
Measured: during Treatment Phase (6 cycles of chemotherapy)
Incidence of serum anti-palifermin antibody formation
Measured: during Treatment Phase (6 cycles of chemotherapy)
Progressive disease rate
Measured: at 6 months
Incidence of secondary primary tumors
Measured: within long-term follow-up phase
Incidence of other malignancies
Measured: within long-term follow-up phase
Progression-free survival (PFS)
Measured: within long-term follow-up phase
Overall survival (OS)
Measured: within long-term follow-up phase
Incidence of grade ≥ 2 (WHO scale) oral mucositis
Measured: in Cycle 2 of chemotherapy treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393822
- Sponsor's protocol ID
- 20040122
- Status last verified
- Jul 2014
- First submitted
- 26 Oct 2006
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00393822
- Acronym / sponsor ID
- 20040122
- Conditions
- Colon Cancer
- Keywords
- KGF, Palifermin, Oral Mucositis, Clinical Trial, Amgen, Oncology, Colon Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palifermin | Experimental | Drug: palifermin50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. |
| Control Group | Placebo comparator | Drug: placebo50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paliferminAlso: KGFdose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles | Drug | Palifermin |
| placeboAlso: Pboone bolus IV injection at 120 μg/kg/day of matched placebo | Drug | Control Group |
Primary outcome
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 1 of chemotherapy treatment phase
12 secondary outcomes
Incidence of chemotherapy (5-FU) dose reductions and dose delays
Time frame: in Cycle 2 of chemotherapy treatment phase
Average mouth and throat soreness (MTS) score
Time frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Duration of grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 1 and in Cycle 2 of chemotherapy treatment phase
Incidence and severity of adverse events
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Changes in laboratory values
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Incidence of serum anti-palifermin antibody formation
Time frame: during Treatment Phase (6 cycles of chemotherapy)
Progressive disease rate
Time frame: at 6 months
Incidence of secondary primary tumors
Time frame: within long-term follow-up phase
Incidence of other malignancies
Time frame: within long-term follow-up phase
Progression-free survival (PFS)
Time frame: within long-term follow-up phase
Overall survival (OS)
Time frame: within long-term follow-up phase
Incidence of grade ≥ 2 (WHO scale) oral mucositis
Time frame: in Cycle 2 of chemotherapy treatment phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing palifermin in people with Colon Cancer, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥ 2 (WHO scale) oral mucositis (time frame: in Cycle 1 of chemotherapy treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.