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

December 4, 2012 updated by: Carolyn N. Krasner, MD, Massachusetts General Hospital

A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer

The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Carolyn Krasner, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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