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| Tracking Information | |||||
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| First Received Date ICMJE | May 3, 2004 | ||||
| Last Updated Date | December 14, 2009 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Overall response rate [ Time Frame: Every six weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00082212 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Relationship between response, dose, and occurence of rash [ Time Frame: Every six weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma | ||||
| Official Title ICMJE | A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma | ||||
| Brief Summary | The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma. |
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| Detailed Description | To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE | Biological: Cetuximab
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Other Name: Erbitux |
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| Study Arms / Comparison Groups | 1: Experimental
400 mg/m2 loading dose, 250 mg/m2 weekly X 2 Cycles
Intervention: Biological: Cetuximab |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00082212 | ||||
| Responsible Party | Chief Medical Officer, ImClone LLC | ||||
| Study ID Numbers ICMJE | CA225-046 | ||||
| Study Sponsor ICMJE | ImClone LLC | ||||
| Collaborators ICMJE | Bristol-Myers Squibb | ||||
| Investigators ICMJE |
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| Information Provided By | ImClone LLC | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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