Status:
COMPLETED
Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Ovarian Cancer
Peritoneal Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00181688
Start Date
October 1 2003
End Date
March 1 2006
Last Update
December 5 2012
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115