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| Sponsored by: |
AGO Ovarian Cancer Study Group |
| Information provided by: | AGO Ovarian Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00189358 |
Purpose
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.
| Condition | Intervention | Phase |
|
Ovarian Cancer Cancer of the Fallopian Tube Peritoneal Cancer |
Drug: ZD1839 Drug: tamoxifen |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | ZD1839 Tamoxifen Tamoxifen citrate Tyrosine |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Germany | |||||
| Dept. of Gynecology, Evangelisches Krankenhaus | |||||
| Duesseldorf, Germany, 40217 | |||||
| AGO Ovarian Cancer Study Group |
| Principal Investigator: | Uwe Wagner, Prof.Dr. | AGO Ovarian Cancer Study Group |
More Information
| Study ID Numbers: | AGO-OVAR 2.6 |
| First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| ClinicalTrials.gov Identifier: | NCT00189358 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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