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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

This study has been completed.
Study NCT00189358.   Last updated on September 12, 2005.   Information provided by AGO Ovarian Cancer Study Group

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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.

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
Condition  Ovarian Cancer
Cancer of the Fallopian Tube
Peritoneal Cancer
Intervention  Drug: ZD1839
Drug: tamoxifen
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
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

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 
Principal Investigator:     Uwe Wagner, Prof.Dr.     AGO Ovarian Cancer Study Group    
Information Provided By AGO Ovarian Cancer Study Group
Verification Date September 2005
First Received Date  September 12, 2005
Last Updated Date September 12, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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