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Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iressa (ZD1839)
Arimidex (Anastrozole)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Iressa, ZD1839, Anastrozole, Arimidex

Eligibility Criteria

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

Inclusion Criteria: Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma Asymptomatic from ovarian cancer Evidence of recurrent ovarian, peritoneal or tubal carcinoma Tumor sample must be positive for ER and/or PR 18 years of age or older ECOG performance status of less than or equal to 1 Must be able to tolerate oral intake Exclusion Criteria: Known hypersensitivity to Iressa or any of the excipients of this product Other coexisting malignancies or malignancies diagnosed within the last 5 years Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort Treatment with a non-approved or investigational drug within 30 days Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia) Incomplete healing from previous oncologic or other major surgery Serum creatinine level greater than CTC grade 2 Pregnant or breast feeding Severe uncontrolled systemic disease Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment Patients previously treated with anastrozole or other aromatase inhibitor Unable to tolerate oral medications Clinical and/or radiographic evidence of current or impending bowel obstruction

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.

Secondary Outcome Measures

To define the median time to progression of this patient population
to assess the tumor response and safety of this treatment.

Full Information

First Posted
September 12, 2005
Last Updated
December 4, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00181688
Brief Title
Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
Official Title
A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
Detailed Description
Patients will receive Iressa and anastrozole orally once daily until treatment is ended. Treatment will end if any of the following occur: Unacceptable adverse effects; bowel obstruction; initiation of systemic chemotherapy; development of new ascites or pleural effusions, development of co-morbid disease or disease progression. Patients will be given a drug log in which to record the date and time they take their pills, as well as any symptoms and concomitant medications. Patients will be seen monthly for the following tests and procedures; a physical examination and repeat blood work. Patients who remain free of clinical symptoms should have repeat abdominal/pelvic CT scans and chest x-rays on an every 3 month basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma
Keywords
Iressa, ZD1839, Anastrozole, Arimidex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Iressa (ZD1839)
Intervention Type
Drug
Intervention Name(s)
Arimidex (Anastrozole)
Primary Outcome Measure Information:
Title
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary Outcome Measure Information:
Title
To define the median time to progression of this patient population
Title
to assess the tumor response and safety of this treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic history diagnosis of primary ovarian, primary peritoneal or tubal carcinoma Asymptomatic from ovarian cancer Evidence of recurrent ovarian, peritoneal or tubal carcinoma Tumor sample must be positive for ER and/or PR 18 years of age or older ECOG performance status of less than or equal to 1 Must be able to tolerate oral intake Exclusion Criteria: Known hypersensitivity to Iressa or any of the excipients of this product Other coexisting malignancies or malignancies diagnosed within the last 5 years Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital or St. John's wort Treatment with a non-approved or investigational drug within 30 days Any unresolved chronic toxicity greater than CTC grad 2 from previous anticancer therapy (except alopecia) Incomplete healing from previous oncologic or other major surgery Serum creatinine level greater than CTC grade 2 Pregnant or breast feeding Severe uncontrolled systemic disease Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment Patients previously treated with anastrozole or other aromatase inhibitor Unable to tolerate oral medications Clinical and/or radiographic evidence of current or impending bowel obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Krasner, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

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