Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00181688 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Last Update Posted
: December 5, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Peritoneal Carcinoma Tubal Carcinoma | Drug: Iressa (ZD1839) Drug: Arimidex (Anastrozole) | Phase 2 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 35 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | March 2006 |

- To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
- To define the median time to progression of this patient population
- to assess the tumor response and safety of this treatment.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181688
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Carolyn Krasner, MD | Massachusetts General Hospital |
Responsible Party: | Carolyn N. Krasner, MD, PI, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181688 History of Changes |
Other Study ID Numbers: |
03-250 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | December 5, 2012 |
Last Verified: | December 2012 |
Keywords provided by Carolyn N. Krasner, MD, Massachusetts General Hospital:
Iressa ZD1839 Anastrozole Arimidex |
Additional relevant MeSH terms:
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Anastrozole Gefitinib Antineoplastic Agents, Hormonal Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Protein Kinase Inhibitors |