Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients W... | NCT00181688

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

NCT00181688

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Dec 5, 2012Estimated

Enrollment

Phase

Phase 2

Conditions

Ovarian Cancer
Peritoneal Carcinoma
Tubal Carcinoma

Interventions

Iressa (ZD1839)
Arimidex (Anastrozole)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 5, 2012Estimated

Name	Class
Dana-Farber Cancer Institute	OTHER
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

ID	Term
D000077156	Gefitinib
D000077384	Anastrozole

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Dana-Farber Cancer Institute