Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 12, 2005
December 4, 2012
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
Not Provided
Not Provided
 
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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Peritoneal Carcinoma
  • Tubal Carcinoma
  • Drug: Iressa (ZD1839)
  • Drug: Arimidex (Anastrozole)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
03-250
Yes
Carolyn N. Krasner, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
Principal Investigator: Carolyn Krasner, MD Massachusetts General Hospital
Massachusetts General Hospital
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP