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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181688
• Other study ID #: 03-250
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 4, 2012
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: December 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Carcinoma
• Tubal Carcinoma

Intervention

Drug:
• Iressa (ZD1839)

• Arimidex (Anastrozole)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary	To define the median time to progression of this patient population
Secondary	to assess the tumor response and safety of this treatment.