Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00971932 |
Recruitment Status :
Completed
First Posted : September 4, 2009
Results First Posted : August 10, 2012
Last Update Posted : April 8, 2014
|
Sponsor:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 3, 2009 | |||
First Posted Date ICMJE | September 4, 2009 | |||
Results First Submitted Date ICMJE | July 4, 2012 | |||
Results First Posted Date ICMJE | August 10, 2012 | |||
Last Update Posted Date | April 8, 2014 | |||
Study Start Date ICMJE | July 2009 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria [ Time Frame: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011 ] Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).
|
|||
Original Primary Outcome Measures ICMJE |
Best overall response according to modified WHO criteria. [ Time Frame: The above measurments will be taken at a 6-weeks interval up to progression of disease. ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Best overall response according to RECIST criteria, disease control rate, duration of response, PFS and time to treatment failure according to WHO criteria will be also measured. [ Time Frame: The above measurments will be taken at a 6-weeks interval up to progression of disease. ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) | |||
Official Title ICMJE | Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects | |||
Brief Summary | The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Squamous Cell Carcinoma of the Head and Neck | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Experimental: Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU)
Interventions:
|
|||
Publications * | Yoshino T, Hasegawa Y, Takahashi S, Monden N, Homma A, Okami K, Onozawa Y, Fujii M, Taguchi T, de Blas B, Beier F, Tahara M. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
33 | |||
Original Estimated Enrollment ICMJE |
31 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00971932 | |||
Other Study ID Numbers ICMJE | EMR 62241-056 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Merck KGaA, Darmstadt, Germany | |||
Original Responsible Party | Yoshiteru Ishikawa, Manager, Clinical Operations, Merck Serono Co.Ltd, an Affiliate of Merck KGaA, Darmstadt, Germany | |||
Current Study Sponsor ICMJE | Merck KGaA, Darmstadt, Germany | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Merck KGaA, Darmstadt, Germany | |||
Verification Date | March 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |