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
NCT00189358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2010-07-20
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.
Conditions
- Ovarian Cancer
- Cancer of the Fallopian Tube
- Peritoneal Cancer
Interventions
- DRUG
-
ZD1839
- DRUG
-
tamoxifen
Sponsors & Collaborators
-
AGO Study Group
lead OTHER
Principal Investigators
-
Uwe Wagner, Prof.Dr. · AGO Study Group
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Germany
Study Locations
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