Clinical trial NCT00181688: Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
Official title: A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Carcinoma
Tubal Carcinoma
Keywords: Iressa
ZD1839
Anastrozole
Arimidex
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
First posted: 2005-09-16
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary outcomes:
measure: To define the median time to progression of this patient population
measure: to assess the tumor response and safety of this treatment.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Carolyn Krasner, MD
role: PRINCIPAL_INVESTIGATOR
References: