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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Carcinoma, Tubal Carcinoma

Thank you

Trial Information

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

- 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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Carolyn Krasner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

October 2003

Completion Date:

March 2006

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Carcinoma
  • Tubal Carcinoma
  • Iressa
  • ZD1839
  • Anastrozole
  • Arimidex
  • Carcinoma
  • Ovarian Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617