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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

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
AGO Study Group
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
September 12, 2005
Last Updated
July 19, 2010
Sponsor
AGO Study Group
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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
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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
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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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