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

NCT ID: NCT00181688

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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* 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.

Conditions

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Ovarian Cancer Peritoneal Carcinoma Tubal Carcinoma

Keywords

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Iressa ZD1839 Anastrozole Arimidex

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Iressa (ZD1839)

Intervention Type DRUG

Arimidex (Anastrozole)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carolyn N. Krasner, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Krasner, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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03-250

Identifier Type: -

Identifier Source: org_study_id