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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Safety and tolerability | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-Based Therapy | ||||
| Official Title ICMJE | A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-Based Therapy | ||||
| Brief Summary | Although initially responsive to cytoreductive surgery and platinum- and/or taxane-based chemotherapy, a majority of patients with epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum will eventually relapse. Recurrence within 6 months after completing platinum-containing chemotherapy indicates a platinum-refractory cancer disease. New therapeutic strategies are required in platinum-refractory disease. Inhibition of growth signals induced by the epidermal growth factor receptor pathway, or by the estrogen receptor pathway provides promising targets in epithelial ovarian cancer, cancer of the fallopian tube or the peritoneum. The trial is to evaluate the safety and tolerability of the combination of the epidermal growth facto tyrosine kinase inhibitor ZD1839 and the clinically established antiestrogen tamoxifen. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: histologically confirmed epithelial ovarian cancer, cancer of the fallopian tube or peritoneum refractory to platinum- and taxane-based chemotherapy measurable or non-measurable disease written informed consent aged 18 years or older Karnofsky performance status > 60% Exclusion Criteria: complete bowel obstruction symptomatic brain metastases known hypersensitivity to evaluated drugs inadequate kidney function inadequate hepatic function evidence of clinically active interstitial lung disease history of congestive heart failure > NYHA 2 |
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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 | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00189358 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | AGO-OVAR 2.6 | ||||
| Study Sponsor ICMJE | AGO Ovarian Cancer Study Group | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | AGO Ovarian Cancer Study Group | ||||
| Verification Date | September 2005 | ||||
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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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