Back to resultsA 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
Primary Purpose
Ovarian Cancer, Cancer of the Fallopian Tube, Peritoneal Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
ZD1839
tamoxifen
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring cancer, cancer alternative therapies, ovarian cancer, tyrosine kinase inhibitor
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
Sites / Locations
- Dept. of Gynecology, Evangelisches Krankenhaus
Outcomes
Primary Outcome Measures
Safety and tolerability
Secondary Outcome Measures
objective response rate
time to progression
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00189358
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
AGO Study Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Cancer of the Fallopian Tube, Peritoneal Cancer
Keywords
cancer, cancer alternative therapies, ovarian cancer, tyrosine kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD1839
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Primary Outcome Measure Information:
Title
Safety and tolerability
Secondary Outcome Measure Information:
Title
objective response rate
Title
time to progression
Title
overall survival
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Wagner, Prof.Dr.
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Gynecology, Evangelisches Krankenhaus
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17161453
Citation
Wagner U, du Bois A, Pfisterer J, Huober J, Loibl S, Luck HJ, Sehouli J, Gropp M, Stahle A, Schmalfeldt B, Meier W, Jackisch C; AGO Ovarian Cancer Study Group. Gefitinib in combination with tamoxifen in patients with ovarian cancer refractory or resistant to platinum-taxane based therapy--a phase II trial of the AGO Ovarian Cancer Study Group (AGO-OVAR 2.6). Gynecol Oncol. 2007 Apr;105(1):132-7. doi: 10.1016/j.ygyno.2006.10.053. Epub 2006 Dec 11.
Results Reference
result
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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
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