Trial · NCT00705016
Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT00705016, Phase 1, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2014-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). Trials, record NCT00705016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705016
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- NCT number
- NCT00705016
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 184 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Squamous Cell Cancer
- Interventions
- Cilengitide 2000 mg once weekly, Cilengitide 2000 mg twice weekly, Cetuximab, 5-fluorouracil (5-FU), Cisplatin
- First posted
- 2008-06-25
- Last updated
- 2014-04-30
- Other registries' IDs
- eudract:2008-000615-15
- Results first posted
- 2014-04-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Time: Investigator Read | 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) | 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. |
| Secondary | Overall Survival (OS) Time | Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) | 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. |
| Secondary | Best Overall Response (BOR) Rate | 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) | 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). |
| Secondary | Disease Control Rate | 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) | 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). |
| Secondary | Time to Treatment Failure (TTF) | 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) | 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. |
| Secondary | Duration of Response | 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) | 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. |
| Secondary | Safety - Number of Participants Experiencing Any Adverse Event | 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) | Please refer to Adverse Events section for details of individual serious adverse events and other adverse events |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Time: Investigator Read | 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) | Intention-to-treat (ITT) population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) Time | Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Rate | 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) | ITT population included all participants who were randomized to trial treatment. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate | 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) | ITT population included all participants who were randomized to trial treatment. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) | 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) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Duration of Response | 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) | ITT population included all participants who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Safety - Number of Participants Experiencing Any Adverse Event | 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 population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Time: Investigator Read | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 6.4 | 95% Confidence Interval 5.4 to 8.7 | months | |
| Progression-free Survival (PFS) Time: Investigator Read | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 5.6 | 95% Confidence Interval 4.0 to 6.1 | months | |
| Progression-free Survival (PFS) Time: Investigator Read | Cetuximab+5-FU+Cisplatin | 5.7 | 95% Confidence Interval 4.2 to 9.5 | months | |
| Overall Survival (OS) Time | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 12.4 | 95% Confidence Interval 9.4 to 14.5 | months | |
| Overall Survival (OS) Time | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 10.6 | 95% Confidence Interval 9.0 to 14.8 | months | |
| Overall Survival (OS) Time | Cetuximab+5-FU+Cisplatin | 11.6 | 95% Confidence Interval 7.1 to 16.4 | months | |
| Best Overall Response (BOR) Rate | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 46.8 | 95% Confidence Interval 34.0 to 59.9 | percentage of participants | |
| Best Overall Response (BOR) Rate | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 26.7 | 95% Confidence Interval 16.1 to 39.7 | percentage of participants | |
| Best Overall Response (BOR) Rate | Cetuximab+5-FU+Cisplatin | 35.5 | 95% Confidence Interval 23.7 to 48.7 | percentage of participants | |
| Disease Control Rate | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 85.5 | 95% Confidence Interval 74.2 to 93.1 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 62 | |
| Overall Study | STARTED | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 60 | |
| Overall Study | STARTED | Cetuximab+5-FU+Cisplatin | 62 | |
| Overall Study | COMPLETED | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 2 | |
| Overall Study | COMPLETED | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 2 | |
| Overall Study | COMPLETED | Cetuximab+5-FU+Cisplatin | 4 | |
| Overall Study | NOT COMPLETED | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 60 | |
| Overall Study | NOT COMPLETED | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 58 | |
| Overall Study | NOT COMPLETED | Cetuximab+5-FU+Cisplatin | 58 |
Source ClinicalTrials.gov
Adverse events663
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 36 | 61 | 98 |
| other | Nausea | Gastrointestinal disorders | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 31 | 59 | 78 |
| other | Nausea | Gastrointestinal disorders | Cetuximab+5-FU+Cisplatin | 40 | 62 | 137 |
| other | Stomatitis | Gastrointestinal disorders | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 27 | 61 | 85 |
| other | Stomatitis | Gastrointestinal disorders | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 28 | 59 | 77 |
| other | Stomatitis | Gastrointestinal disorders | Cetuximab+5-FU+Cisplatin | 30 | 62 | 83 |
| other | Vomiting | Gastrointestinal disorders | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 28 | 61 | 66 |
| other | Vomiting | Gastrointestinal disorders | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 24 | 59 | 55 |
| other | Vomiting | Gastrointestinal disorders | Cetuximab+5-FU+Cisplatin | 28 | 62 | 96 |
| other | Diarrhoea | Gastrointestinal disorders | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 23 | 61 | 45 |
1 to 10 of 663Source ClinicalTrials.gov
See all 663 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | ||
| Total, all-cause mortality | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | ||
| Total, all-cause mortality | Cetuximab+5-FU+Cisplatin | ||
| Total, other adverse events | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 61 | 61 |
| Total, other adverse events | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 57 | 59 |
| Total, other adverse events | Cetuximab+5-FU+Cisplatin | 61 | 62 |
| Total, serious adverse events | Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin | 41 | 61 |
| Total, serious adverse events | Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin | 45 | 59 |
| Total, serious adverse events | Cetuximab+5-FU+Cisplatin | 44 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24567516 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00705016
GET https://conductscience.org/api/trials/v1/NCT00705016/results?page=2