Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Carolyn N. Krasner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181688
First received: September 12, 2005
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
The main purpose of this study is to determine the effects (good and bad) Iressa plus anastrozole has on patients with relapsed ovarian cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Carcinoma Tubal Carcinoma |
Drug: Iressa (ZD1839) Drug: Arimidex (Anastrozole) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of ZD1839 (Iressa) Plus Anastrozole (Arimidex) in Patients With Relapsed Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.
Secondary Outcome Measures:
- To define the median time to progression of this patient population
- to assess the tumor response and safety of this treatment.
| Estimated Enrollment: | 35 |
| Study Start Date: | October 2003 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181688
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181688
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
| Principal Investigator: | Carolyn Krasner, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Carolyn N. Krasner, MD, PI, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181688 History of Changes |
| Other Study ID Numbers: | 03-250 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 30, 2016