A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Carolyn N. Krasner, MD
PI
Massachusetts General Hospital
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
Outcomes
Primary Outcomes
To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary Outcomes
- To define the median time to progression of this patient population
- to assess the tumor response and safety of this treatment.