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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00181688

First Posted: September 16, 2005

Last Update Posted: December 5, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Information provided by (Responsible Party):

Carolyn N. Krasner, MD, Massachusetts General Hospital

Purpose

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

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Carcinoma Tubal Carcinoma	Drug: Iressa (ZD1839) Drug: Arimidex (Anastrozole)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Drug Information available for: Anastrozole Gefitinib

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Carolyn N. Krasner, MD, Massachusetts General Hospital:

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.


Estimated Enrollment:	35
Study Start Date:	October 2003
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181688

Locations


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

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators


Principal Investigator:	Carolyn Krasner, MD	Massachusetts General Hospital

More Information


Responsible Party:	Carolyn N. Krasner, MD, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181688 History of Changes
Other Study ID Numbers:	03-250
First Submitted:	September 12, 2005
First Posted:	September 16, 2005
Last Update Posted:	December 5, 2012
Last Verified:	December 2012

Keywords provided by Carolyn N. Krasner, MD, Massachusetts General Hospital:


Iressa ZD1839 Anastrozole Arimidex

Additional relevant MeSH terms:


Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders	Anastrozole Gefitinib Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Protein Kinase Inhibitors

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