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| Descriptive Information Fields | |||||
| Brief Title † | 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 † | 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 † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Safety and tolerability | ||||
| Secondary Outcome Measure † | objective response rate time to progression overall survival |
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| Condition † | Ovarian Cancer Cancer of the Fallopian Tube Peritoneal Cancer |
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| Intervention † | Drug: ZD1839 Drug: tamoxifen |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
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| Eligibility Criteria † | 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 †† | |||||
| Location Countries † | Germany | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00189358 | ||||
| Organization ID | AGO-OVAR 2.6 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | AGO Ovarian Cancer Study Group | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | AGO Ovarian Cancer Study Group | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||