A Phase 2 interventional study of Cetuximab in Carcinoma of the Head and Neck, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 4 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-03-12.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 2, Interventional, and Treatment
This study is conducted in Japanese newly diagnosed locally advanced SCCHN patients in order to assess tolerability and feasibility of Cetuximab plus concomitant boost radiotherapy (RT) regimen (the study treatment) and its safety profile (i.e. AEs: adverse events). In addition, efficacy (i.e. anti-tumor effect) of the study treatment is also evaluated.
Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Cetuximab
Patients receive Cetuximab at an initial dose of 400 mg/m\^2 of Cetuximab to be infused 6 or 7 days before starting radiotherapy, followed by subsequent weekly infusions at a dose of 250 mg/m\^2 of Cetuximab and RT (72.0 Gy total in 42 fractions) for the next 6 weeks of the treatment course. Subjects will receive Cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of Cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with Cetuximab monotherapy every 7 days is continued.
Completion Rate
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
Time frame: time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks
Best Response Rate
Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (\>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population
Time frame: best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required
Safety - Number of Patients Experiencing Any Adverse Event
Please refer to Adverse Events section for further details
Time frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
Safety - Number of Patients Experiencing Any Grade 4 Adverse Event
Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.
Time frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction
Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Time frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction
Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
Time frame: time from first dose up to 60 days after last dose of study treatment, ≤18 weeks
Subjects were enrolled in this study at 4 centers in Japan. The first subject was enrolled on 06 March 2009 and the last on 04 January 2010.
| Milestone | Cetuximab With Radiotherapy |
|---|---|
| Started | 22 |
| Completed | 21 |
| Not completed | 1 |
| Withdrew: Progressive disease | 1 |
Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population
| percentage of participants | Cetuximab With Radiotherapy |
|---|---|
| Completion Rate | 100 (84.6 to 100.0) |
Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (\>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population
| percentage of participants | Cetuximab With Radiotherapy |
|---|---|
| Best Response Rate | 81.8 (59.7 to 94.8) |
Please refer to Adverse Events section for further details
| participants | Cetuximab With Radiotherapy |
|---|---|
| Safety - Number of Patients Experiencing Any Adverse Event | 22 |
Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject's health and well-being, and the ability of the subject to function during the event.
| participants | Cetuximab With Radiotherapy |
|---|---|
| Safety - Number of Patients Experiencing Any Grade 4 Adverse Event | 2 |
Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
| participants | Cetuximab With Radiotherapy |
|---|---|
| Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction | 3 |
Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.
| participants | Cetuximab With Radiotherapy |
|---|---|
| Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction | 0 |
Collected over Time from first dose up to 60 days after the last dose of study treatment. Adverse Events (AEs) are summarized using the MedDRA version 13.0.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cetuximab With Radiotherapy | — | 3/22 (13.6%) | 22/22 (100%) |
| Event | Cetuximab With Radiotherapy |
|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 1/22 |
| DehydrationMetabolism and nutrition disorders | 1/22 |
| Altered state of consciousnessNervous system disorders | 1/22 |
| Event | Cetuximab With Radiotherapy |
|---|---|
| Mucosal inflammationGeneral disorders | 19/22 |
| Dry mouthGastrointestinal disorders | 17/22 |
| ConstipationGastrointestinal disorders | 15/22 |
| DysgeusiaNervous system disorders | 15/22 |
| Dry skinSkin and subcutaneous tissue disorders | 15/22 |
| AcneSkin and subcutaneous tissue disorders | 14/22 |
| PyrexiaGeneral disorders | 11/22 |
| DermatitisSkin and subcutaneous tissue disorders | 11/22 |
| DiarrhoeaGastrointestinal disorders | 10/22 |
| Radiation skin injuryInjury, poisoning and procedural complications | 10/22 |
| Age, Categorical(Participants) | Cetuximab With Radiotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 15 |
| Age, Continuous(years) | Cetuximab With Radiotherapy |
|---|---|
| Mean | 67.6 ± 6.59 |
| Sex: Female, Male(Participants) | Cetuximab With Radiotherapy |
|---|---|
| Female | 1 |
| Male | 21 |
| Region of Enrollment(participants) | Cetuximab With Radiotherapy |
|---|---|
| Japan | 22 |
The record gives a start of Mar 2009, a primary completion of Jun 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2011, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cetuximab
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