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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
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Carolyn N. Krasner, MD, Massachusetts General Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Carcinoma Tubal Carcinoma Drug: Iressa (ZD1839) Drug: Arimidex (Anastrozole) Phase 2

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To define the median time to termination of treatment with Iressa and anastrozole in patients with asymptomatic relapsed ovarian cancer.

Secondary Outcome Measures :
  1. To define the median time to progression of this patient population
  2. to assess the tumor response and safety of this treatment.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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