| September 12, 2005 |
| December 28, 2007 |
| October 2003 |
| March 2006 (final data collection date for primary outcome measure) |
| To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer. |
| Same as current |
| Complete list of historical versions of study NCT00181688 on ClinicalTrials.gov Archive Site |
- To define the median time to progression of this patient population
- to assess the tumor response and safety of this treatment.
|
| Same as current |
| |
| Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer |
| A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer |
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on 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 basis.
|
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
- Ovarian Cancer
- Peritoneal Carcinoma
- Tubal Carcinoma
|
- Drug: Iressa (ZD1839)
- Drug: Arimidex (Anastrozole)
|
| |
| |
| |
| Completed |
| 35 |
| March 2006 |
| March 2006 (final data collection date for primary outcome measure) |
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
|
| Female |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00181688 |
| Carolyn Krasner, Mass General Hospital |
| 03-250 |
| Massachusetts General Hospital |
- Dana-Farber Cancer Institute
- Brigham and Women's Hospital
|
| Principal Investigator: |
Carolyn Krasner, MD |
Massachusetts General Hospital |
|
|
| Massachusetts General Hospital |
| December 2007 |