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

This study has been completed.

Sponsor:

Collaborators:

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Information provided by (Responsible Party):

Carolyn N. Krasner, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00181688

First received: September 12, 2005

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 4, 2012

Start Date ^ICMJE

October 2003

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00181688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Ovarian Cancer
Peritoneal Carcinoma
Tubal Carcinoma

Intervention ^ICMJE

Drug: Iressa (ZD1839)
Drug: Arimidex (Anastrozole)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00181688

Other Study ID Numbers ^ICMJE

03-250

Has Data Monitoring Committee

Yes

Responsible Party

Carolyn N. Krasner, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Dana-Farber Cancer Institute
Brigham and Women's Hospital

Investigators ^ICMJE

Principal Investigator:

Carolyn Krasner, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top