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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000615-15 | EudraCT Number |
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The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).
The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial, cilengitide is administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.
Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially inhibits the ingrowth of additional blood vessels towards the tumor.
Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin | Experimental |
| |
| Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin | Experimental |
| |
| Cetuximab+5-FU+Cisplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilengitide 2000 mg once weekly | Drug | Cilengitide 500 milligram (mg) will be administered as an intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by 2000 mg dose of cilengitide on Day 8 and 15 of every cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Time: Investigator Read | The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site. | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Time | The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. | Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vermorken, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Salzburg | Austria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24567516 | Result | Vermorken JB, Peyrade F, Krauss J, Mesia R, Remenar E, Gauler TC, Keilholz U, Delord JP, Schafhausen P, Erfan J, Brummendorf TH, Iglesias L, Bethe U, Hicking C, Clement PM. Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). Ann Oncol. 2014 Mar;25(3):682-688. doi: 10.1093/annonc/mdu003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cilengitide 2000 mg twice weekly | Drug | Cilengitide 2000 mg will be administered as an intravenous infusion over 60 minutes, twice weekly on Day 1, 4, 8, 11, 15, and 18 of each 3-week cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants will receive cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
|
| Cetuximab | Drug | Cetuximab will be administered as 250 milligram per square meter (mg/m^2) as infusion (initial starting dose of 400 mg/m^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
| 5-fluorouracil (5-FU) | Drug | 5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first. |
|
| Cisplatin | Drug | Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first. |
|
| Best Overall Response (BOR) Rate | The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0). | Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Disease Control Rate | The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0). | Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Time to Treatment Failure (TTF) | TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Duration of Response | Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death. | Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Safety - Number of Participants Experiencing Any Adverse Event | Please refer to Adverse Events section for details of individual serious adverse events and other adverse events | Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
| Vienna |
| Austria |
| Research Site | Antwerp | Belgium |
| Research Site | Brussels | Belgium |
| Research Site | Edegem (Antwerp) | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Leuven | Belgium |
| Research Site | Namur | Belgium |
| Research Site | Lille | France |
| Research Site | Montpellier | France |
| Research Site | Nice | France |
| Research Site | Toulouse | France |
| Research Site | Tours | France |
| Research Site | Vandœuvre-lès-Nancy | France |
| Research Site | Villejuif | France |
| Research Site | Aachen | Germany |
| Research Site | Berlin | Germany |
| Research Site | Essen | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Jena | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Rostock | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Győr | Hungary |
| Research Site | NyÃregyháza | Hungary |
| Research Site | La Spezia | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | Italy |
| Research Site | Gliwice | Poland |
| Research Site | Warsaw | Poland |
| Research Site | L'Hospitalet de Llobregat | Spain |
| Research Site | Madrid | Spain |
| Research Site | Velencia | Spain |
| Research Site | Basel | Switzerland |
| Research Site | Geneva | Switzerland |
| FG001 | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| FG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| BG001 | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| BG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Out of a total of 62 participants in Cetuximab + 5-FU + Cisplatin group, data for baseline measure (age) was available for 61 participants only. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Out of a total of 62 participants in Cetuximab + 5-FU + Cisplatin group, data for baseline measure (age) was available for 61 participants only. | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Karnofsky Performance Status | Karnofsky performance status score ranged from 100 to 0; 100: Normal; 90: Able to Carry on normal Activity; 80: Normal Activity with Effort; Some Signs or Symptoms of Disease; 70: Cares for Self, Unable to Carry on Normal Activity or to Do Active Work; 60: Requires Occasional Assistance but is Able to Care for Most of Needs; 50: Requires Considerable Assistance and Frequent Medical Care; 40: Disabled, Requires Special Care and Assistance; 30: Severely Disabled; Hospitalization Indicated Although Death is Not Imminent; 20: Very Sick; 10: Moribund, Fatal Processes Progressing Rapidly; 0: Death. | Number | participants |
| |||||||||||||||
| Extent of disease at study entry | Number | participants |
| ||||||||||||||||
| Tumor Grade | Out of a total of 62 participants in Cilengitide 2000 mg once weekly + Cetuximab + 5-FU + Cisplatin group, 60 participants in Cilengitide 2000 mg twice weekly + Cetuximab + 5-FU + Cisplatin group, and 62 participants in Cetuximab + 5-FU + Cisplatin group, data for baseline measure (Tumor grade) was available for 57, 58 and 57 participants only, respectively. Tumor grades were divided in to well or moderately differentiated and poorly differentiated. | Number | participants |
| |||||||||||||||
| Site of origin of tumor | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) Time: Investigator Read | The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site. | Intention-to-treat (ITT) population included all participants who were randomized to trial treatment. | Posted | Median | 95% Confidence Interval | months | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Overall Survival (OS) Time | The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. | ITT population included all participants who were randomized to trial treatment. | Posted | Median | 95% Confidence Interval | months | Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Best Overall Response (BOR) Rate | The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0). | ITT population included all participants who were randomized to trial treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Disease Control Rate | The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0). | ITT population included all participants who were randomized to trial treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Time to Treatment Failure (TTF) | TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. | ITT population included all participants who were randomized to trial treatment. | Posted | Median | 95% Confidence Interval | months | Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Duration of Response | Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death. | ITT population included all participants who were randomized to trial treatment. | Posted | Median | 95% Confidence Interval | months | Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
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| Secondary | Safety - Number of Participants Experiencing Any Adverse Event | Please refer to Adverse Events section for details of individual serious adverse events and other adverse events | Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab. | Posted | Number | participants | Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) |
|
Time from first dose up to 28 days after last dose of study treatment, reported between day of first patient randomized, 01 October 2008, until cut off date, 03 September 2011
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. | 41 | 61 | 61 | 61 | ||
| EG001 | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. | 45 | 59 | 57 | 59 | ||
| EG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. | 44 | 62 | 61 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Duodenal Perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neutropenic Colitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oesophageal Perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tongue Necrosis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermatitis Infected | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oral Fungal Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device Dislocation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombosis In Device | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Catheter Site Inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device Leakage | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Performance Status Decreased | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary Artery Thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Axillary Vein Thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arterial Rupture | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriosclerosis Obliterans | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Depressed Level Of Consciousness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood Amylase Increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood Creatine Increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Glomerular Filtration Rate Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrostomy Failure | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ototoxicity | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tumour Haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraneoplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Infected Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Retinal Artery Thrombosis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acute Hepatic Failure | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Normochromic Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oral Fungal Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C422910 | Cilengitide |
| D000068818 | Cetuximab |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Greater than or equal to (>=) 65 years |
|
| Male |
|
| >= 80 (Karnofsky Score) |
|
| Distant Metastasis |
|
| Poorly differentiated |
|
| Hypopharynx |
|
| Larynx |
|
| Oral cavity |
|
| Other, including non-classifiable |
|
| No |
| Superiority or Other |
| Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%. | Cox proportional hazards model | Stratification factor: Karnofsky performance status (KPS) <80/>=80 | 0.054 | The Type I error was not taken into account, since the sample size calculation is based on selection theory. | Hazard Ratio (HR) | 1.55 | 2-Sided | 95 | 0.99 | 2.43 | No | Superiority or Other |
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
|
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
|
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
|
| OG001 |
| Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin |
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
|
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|
|
Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
| OG002 | Cetuximab+5-FU+Cisplatin | Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason. |
|
|