Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00181688

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Anastrozole ZD1839

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Mass General Hospital ( Carolyn Krasner )
Study ID Numbers:	03-250
Study First Received:	September 12, 2005
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00181688 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Iressa
ZD1839
Anastrozole
Arimidex

Additional relevant MeSH terms:

Anastrozole
Ovarian Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Ovarian Diseases

Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Gefitinib
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009