Iressa (ZD1839) Plus Anastrozole (Arimidex) in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
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
  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)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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

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

No publications provided

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
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014