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

NCT00181688 | Completed Phase 2 DMC

• 1 other identifier: 03-250
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Ovarian Cancer; Peritoneal Carcinoma; Tubal Carcinoma

Keywords

Iressa; ZD1839; Anastrozole; Arimidex

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• To define the median time to progression of this patient population

• to assess the tumor response and safety of this treatment.

Interventions

Iressa (ZD1839) DRUG

Arimidex (Anastrozole) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• ECOG performance status of less than or equal to 1
• Must be able to tolerate oral intake

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Gefitinib; Anastrozole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Carolyn Krasner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

US (2)